The North American Menopause Society (NAMS) is affirming the safety and efficacy of hormone therapy for certain conditions, and in certain populations of menopausal women, in its soon-to-be released 2016 hormone therapy position statement.
An update from the society’s 2012 recommendations, the new statement will also give targeted recommendations for special populations of women to help guide clinicians in individualized treatment.
“We want to remove the fear of using menopausal [hormone therapy] for healthy women under 60 and within 10 years from menopause and to make sure that benefits and risks are discussed with the women in an appropriate way,” JoAnn Pinkerton, MD, NAMS executive director and the lead author of the position statement, said in an interview.
Highlights from the new position statement were released at the NAMS 2016 annual meeting, and the full document is expected to be published later this year. Among the highlights is the assertion that the clearest benefit for hormone therapy (HT) for treating hot flashes and preventing bone loss is in the early postmenopausal group.
The position statement also represents something of a shift away from the old mantra of “the lowest dose for the shortest period of time,” said Dr. Pinkerton , professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville.
As a practical matter, clinicians should budget time for these individualized discussions, Cynthia Stuenkel, MD, another member of the guidelines committee, said in an interview.
“The challenge for many practitioners is that this is not a 4-minute conversation,” said Dr. Stuenkel , professor of endocrinology at the University of California, San Diego.
Currently, HT is approved by the Food and Drug administration as first-line therapy for menopausal vasomotor symptoms (VMS) for women without contraindications. For prevention of bone loss and fractures in postmenopausal women at higher risk, HT may be considered, especially for women younger than 60 years old and less than 10 years post menopause, according to the position statement.
When the predominant symptom pattern involves genitourinary syndrome of menopause (GSM, also known as vulvovaginal atrophy), the position statement recommends starting with low-dose vaginal estrogen as first-line treatment. These are all level I recommendations.
The course correction represented in the 2016 position statement on HT is appropriate, said committee member Andrew M. Kaunitz, MD. “Many clinicians are reluctant to consider prescribing hormone therapy even for appropriate candidates,” said Dr. Kaunitz , professor of ob.gyn. at the University of Florida, Jacksonville. “Bothersome vasomotor symptoms can very much impair quality of life,” he said, noting that sleep disturbances, hot flashes, and other menopausal symptoms can persist for years and are the source of “substantial suffering.”
The use of HT in early menopause both provides the most effective treatment for symptoms and the greatest skeletal benefits, according to Michael R. McClung, MD, founding director of the Oregon Osteoporosis Center in Portland. “The benefit far outweighs the risk,” he said, especially in women at risk for bone density loss without contraindication for HT.
Special populations
Several special populations are addressed in the updated position statement. These include those who have reached early menopause because of primary ovarian insufficiency or because of oophorectomy. For these women, NAMS recommends hormone therapy until at least the median age of menopause. Making a level II recommendation, the NAMS committee wrote, “Observational studies suggest that benefits appear to outweigh the risks for effects on bone, heart, cognition, GSM, sexual function, and mood.”
Other special populations for whom HT may be considered include women with a family history of breast cancer and women who are positive for the BRCA gene. Again turning to observational evidence, the NAMS committee makes a level II recommendation that “use of HT does not alter the risk for breast cancer in women with family history of breast cancer, although family history is one risk, among many, that should be assessed.”
BRCA-positive women who do not have breast cancer are at higher risk for primarily estrogen receptor–negative breast cancer. BRCA-positive women may have opted for elective oophorectomy, though, and the committee recommends considering the potential negative effects of estrogen depletion at a premenopausal age when weighing risks and benefits in surgically menopausal BRCA-positive patients. It’s appropriate to offer systemic HT until the median age of menopause in this population, if there are no contraindications, and after appropriate counseling, according to the position statement.
Individualized discussions about continuing HT beyond the median age of menopause are recommended, said Dr. Pinkerton. “We reviewed the literature and found no increased risk in observational studies of women with BRCA genes after oophorectomy who receive hormone therapy,” she said. “These decisions are best taken on an individual basis.” The recommendations for the BRCA population are also a level II recommendation.
Duration of use
Regarding extended use of HT, the NAMS statement breaks with the Beers criteria, saying that routine discontinuation of HT after the age of 65 years “is not supported by data.” These decisions, according to the new recommendations, should be individualized. This is a level III recommendation. Still, said Dr. Kaunitz, “many women grow out of their vasomotor symptoms,” and so an individualized approach might include indefinite use of low-dose vaginal estrogen therapy for GSM, he said.
The overall benefit-risk ratio for HT is also addressed in the position statement, which emphasizes an individualized approach that includes periodic reassessment of risk and benefit for particular patients. However, for patients younger than 60 years of age, or who are within 10 years of menopause, NAMS endorses an overall favorable risk-benefit profile for HT in two particular areas, barring contraindications. For this younger postmenopausal population, hormone therapy is beneficial for bothersome vasomotor symptoms, according to the position statement, and women with an increased risk of osteoporosis or fracture may also benefit from HT.
The benefit-risk profile may tip against HT for women who are starting hormone therapy more than 10 years after menopause, or when they are 60 years old or older, according to the statement. The authors cite elevated risks of coronary heart disease, stroke, venous thromboembolism, and dementia.
Most HT management decisions can be made in the ob.gyn. or primary care physician’s office, according to Dr. Stuenkel. However, an endocrinology consult might be considered for women with diabetes or other endocrine disorders, or when the symptom picture doesn’t quite fit – when the patient feels you “can’t quite seem to get it right,” she said. Occasionally, a less common condition such as carcinoid or pheochromocytoma may be responsible for vasomotor symptoms. “No one teaches women what hot flashes feel like,” Dr. Stuenkel said.
The recommendations embodied in the new position statement take into account the “substantial benefit” of estrogen for many women, and provide an updated view of the safety of HT, Dr. McClung said. It’s important for physicians to talk to their patients, because “that information has not made it back to the Internet,” he said.
Dr. Pinkerton, Dr. McClung, and Dr. Kaunitz all reported financial relationships with several pharmaceutical companies. Dr. Kaunitz reported receiving royalties from UpToDate. Dr. Stuenkel reported no relevant financial disclosures.
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