The 2017 Hormone Therapy Position Statement of The North American Menopause Society

The North American Menopause Society 2017 Hormone Therapy Position Statement Advisory Panel

Disclosures

The North American Menopause Society (NAMS). 2018;24(7):728-753. 

In This Article

Summary

In the 15 years since the publication of the first results in 2002 from the large WHI HT trials and almost 10 years since the 2007 reanalysis of the results by age and years since menopause, much has been learned, yet much controversy remains.

Hormone therapy formulation, dosing, regimen, route of administration, and the timing of initiation of therapy likely produce different effects, although these have yet to be evaluated in head-to-head RCTs, and there is a significant difference in the benefits and risk of estrogen alone compared with estrogen combined with different progestogens, at least as studied in the WHI. The concept of ''lowest dose for the shortest period of time'' may be inadequate or even harmful for some women. A more fitting concept is ''appropriate dose, duration, regimen, and route of administration.'' Given the more favorable safety profile of estrogen alone, longer durations may be more appropriate. Risk stratification by age and time since menopause is recommended. Transdermal or lower doses of HT may decrease risk of VTE and stroke.

Individualization with shared decision making remains key, with periodic reevaluation to determine an individual woman's benefit-risk profile. Benefits may include relief of bothersome VMS, prevention of bone loss for women at high risk of fracture, treatment of GSM, and improved sleep, well-being, or QOL. Absolute attributable risks for women in the 50- to 59-year-old age group or within 10 years of menopause onset are low, whereas the risks of initiation of HT for women aged 60 years and older or who are further than 10 years from menopause onset appear greater, particularly for those aged 70 years and older or who are more than 20 years from menopause onset, with more research needed on potential risks of longer durations of use.

Women with POI or early surgical or natural menopause have higher risks of bone loss, heart disease, and cognitive or affective disorders associated with estrogen deficiency. In observational studies, this risk appears to approach normal if ET is given until the median age of menopause, at which time treatment decisions should be reevaluated. In limited observational studies, women who are BRCA-positive appear to receive similar benefits from receiving HT until the average age of menopause, with minimal to no increased risks of breast cancer seen. There is a paucity of RCT data about the risks of extended duration of HT in women aged older than 60 or 65 years, although observational studies suggest an increased risk of breast cancer with increased duration of HT. Anticipated CHD benefit, based on long-term follow-up of the Nurses' Health Study, may decline with age. It remains an individual decision in select, well-counseled women aged older than 60 or 65 years to continue therapy. There are no data to support routine discontinuation in women aged 65 years.

For select survivors of breast and endometrial cancer, short-term observational data show that use of low-dose vaginal ET for those who fail nonhormone therapy appears safe and greatly improves QOL for many. The use of systemic HT needs careful consideration for survivors of estrogen-sensitive cancer and should only be used for compelling reasons in conjunction with a woman's cancer specialist after failure of nonhormone therapies.

Additional research is urgently needed on the thrombotic risk (VTE, PE, and stroke) of oral versus transdermal therapies. More clinical trial data are needed to confirm or refute the potential beneficial effects of HT on CHD and all-cause mortality when initiated in perimenopause or early post-menopause. Additional areas for research include the breast effects of different estrogen preparations, including the role for SERM therapies; the relationship between VMS and the risk for heart disease and cognitive changes; and the risks of POI and early surgical menopause. Studies are needed on the effects of longer use of low-dose vaginal ET after breast or endometrial cancer; extended use of HT in women who are early initiators; whether the theorized apoptotic effect of 5 years without estrogen provides additional safety with ET; improved tools to personalize or individualize benefits and risks of HT; the role of aging and genetics; and the long-term benefits and risks on women's health of lifestyle modification or complementary or nonhormone therapies if chosen over HT for VMS relief, bone health, and CVD reduction.

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