North American Menopause Society Releases New Guidelines for Hormone Therapy

Members of the North American Menopause Society (NAMS) have released an updated position statement on hormone therapy use, according to guidelines recently published in Menopause.

JoAnn V. Pinkerton, MD, NCMP, NAMS chair, and colleagues created an advisory panel of clinicians and researchers that provided recommendations for the position statement. The research incorporated literature published after the NAMS hormone therapy position statement in 2012, but focused primarily on randomized controlled trials (RCTs) and results from the Women’s Health Initiative.

 

“In general, the Panel gave greater consideration to findings from larger RCTs or meta-analyses of larger RCTs and reviewed additional published analyses of the [Women’s Health Initiative] findings; newer outcomes from smaller RCTs; longitudinal observational studies; and additional metaanalyses,” Dr Pinkerton and colleagues wrote in a summary of the recommendations.

The advisory panel decided on recommendations for hormone therapy with regard to formulation, dosing, administration, and safety; FDA-approved indications; compounded hormones; menopause symptoms; early natural menopause; skin, hair, and special senses; and oophorectomy in premenopausal women.

They also examined the relationship between hormone therapy and quality of life, as well as the effects on conditions such as osteoporosis, joint pain, sarcopenia, gallbladder, liver, diabetes mellitus, and metabolic syndrome. Body composition, mood, depression, cognition, cardiovascular disease, and all-cause mortality were also considered, as well as hormone therapy’s relationship to various cancers (breast, endometrial, ovarian, colorectal, and lung, among others).

The panel made the following statements and recommendations about hormone therapy use for postmenopausal women.

• Hormone therapy is the most effective treatment for vasomotor symptoms and genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture.
• Risks associated with hormone therapy differ among women, depending on type, dose, duration, route of administration, timing of initiation, and whether a progestogen is needed. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation for the benefits and risks of continuing hormone therapy.
• For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio appears favorable for treatment of bothersome vasomotor symptoms and for those at elevated risk for bone loss or fracture. Longer duration may be more favorable for estrogen therapy than for estrogen progestogen therapy, based on the Women’s Health Initiative RCTs.
• For women who initiate hormone therapy more than 10 or 20 years from menopause onset or when aged 60 years or older, the benefit-risk ratio appears less favorable compared with younger women because of greater absolute risks for coronary heart disease, stroke, venous thromboembolism, and dementia.
• For GSM symptoms not relieved with over-the-counter or other therapies, low-dose vaginal estrogen therapy is recommended.

“Additional research is urgently needed on the thrombotic risk ([venous thromboembolism], [pulmonary embolism], and stroke) of oral vs transdermal therapies,” Dr Pinkerton and colleagues wrote. “More clinical trial data are needed to confirm or refute the potential beneficial effects of [hormone therapy] on [coronary heart disease] and all-cause mortality when initiated in perimenopause or early postmenopause.

“Additional areas for research include the breast effects of different estrogen preparations, including the role for [selective estrogen receptor modulator] therapies; the relationship between [vasomotor symptoms] and the risk for heart disease and cognitive changes; and the risks of [primary ovarian insufficiency] and early surgical menopause.”