'Change the Conversation' About Hormone Therapy in Menopause

Tara Haelle

October 13, 2017

PHILADELPHIA — The new position statement on hormone therapy from the North American Menopause Society is in the public eye here at the 2017 annual meeting, where fears about treatment are being discussed and women and healthcare providers are being reassured that hormone therapy is safe and effective for menopausal symptoms that disrupt a woman's quality of life (Menopause. 2017;24:728-753).

"Fear has been driving the conversation about hormone therapy," said JoAnn Pinkerton, MD, from the Midlife Health Center at the University of Virginia in Charlottesville, who is executive director of NAMS and chair of the 20-member position statement advisory panel.

But "hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause, and has been shown to prevent bone loss and fracture," she said.

Hormone therapy is approved by the US Food and Drug Administration for vasomotor symptoms in women without contraindications; the prevention of bone loss and fractures in postmenopausal women at high risk for osteoporosis or fracture; and premature surgical menopause, hypogonadism, and primary ovarian insufficiency until average menopausal age is reached (as long as there are no contraindications). And for women experiencing only genitourinary menopausal symptoms, low-dose vaginal estrogen therapy is first-line, rather than systemic, therapy.

Since the 2002 publication of findings from the Women's Health Initiative (WHI), anxiety about risk for breast cancer, heart disease, and dementia have dominated clinical discussions about hormone therapy. However, follow-up data from the WHI, including a study published this year, as reported by Medscape Medical News, show no increase in cardiovascular, cancer, or all-cause mortality.

Fear has been driving the conversation about hormone therapy.

"We really want clinicians to change the conversation with women," Dr Pinkerton told Medscape Medical News. "We want them to feel very comfortable that if a woman is having bothersome menopausal systems — hot flashes, night sweats, sleep disturbances — hormone therapy is safe and effective, primarily for women who are starting hormone therapy if they are under 60 and within 10 years of menopause, where there are more benefits than risks."

Dr Pinkerton emphasized the differences in risk between estrogen therapy and estrogen with progestin. Estrogen-only therapy, for example, appears to have a better safety profile for longer use.

This position statement will likely reduce some of the fears women and their clinicians still harbor about hormone therapy, said Mache Seibel, MD, menopause expert and resident trainer at the Beth Israel Deaconess Medical Center in Boston.

The pendulum is swinging back in favor of hormone therapy.

"The pendulum is swinging back in favor of hormone therapy," he told Medscape Medical News. And "it helps clear the air in terms of removing fear and confusion about menopause and the appropriateness of considering hormone therapy."

It typically takes about an hour to consult with patients about menopause because it requires additional time to allay women's fear about hormone therapy, said Dr Seibel, author of The Estrogen Fix, a new book about hormone therapy.

"The hormone therapy benefits versus risks have been so confusing that the majority of women and many of their doctors still don't accept that the risks are much less than the benefits," he said.

Benefits and Risks of Therapy

The effects of hormone therapy vary with a woman's age and time since menopause.

For cardiovascular disease, there does not appear to be an elevation in risk for women who begin hormone therapy more than 10 or 20 years after menopause, but some data show a reduced cardiovascular risk for younger women.

A meta-analysis of randomized controlled studies showed that for women who start hormone therapy less than 10 years after the onset of menopause, there is a 48% reduction in the risk for coronary heart disease (relative risk [RR], 0.52; 95% confidence interval [CI], 0.29 - 0.96) and a 30% reduction in the risk for cardiovascular death (RR, 0.70; 95% CI, 0.52 - 0.95) (Cochrane Database Syst Rev. 2015;3:CD002229).

However, the risk for venous thromboembolism was elevated (RR, 1.74; 95% CI, 1.11 - 2.73). And as women age, the meta-analysis showed a gradual increase in the risk for stroke, venous thromboembolism, and pulmonary embolism.

The risk for breast cancer related to hormone therapy is more complex, Dr Pinkerton explained. Data are conflicting, and the risk might depend on the type of therapy a woman uses (estrogen alone appears to have a lower risk), dose, duration of use, route of administration, regimen, previous exposure to hormone therapy, and her individual characteristics and risk history.

In addition, evidence shows that the risk for lung cancer is neutral and the risk for ovarian cancer might be slightly elevated after long-term use. For colon cancer, hormone therapy might protective, although data are limited and observational.

The position statement addresses special populations: survivors of breast or endometrial cancer, women being treated for endometrial cancer, women older than 65 years, and women who experience early menopause, primary ovarian insufficiency, or who have undergone oophorectomy because of a BRCA mutation.

The statement also lays out the evidence for hormone therapy related to specific vasomotor symptoms, sleep, endometrial health and protection, sexual function, bone and joint protection, cognition, mood, type 2 diabetes, gallbladder and liver health, and overall quality of life. Systemic therapy reduces night-time awakenings and sleep disruptions and improves sleep duration and cycles, particularly in women experiencing hot flashes.

In women taking estrogen — alone or with progesterone — there is a 33% reduction in the risk for hip fracture, and less joint pain and stiffness.

Hormone therapy is also associated with a decreased risk for type 2 diabetes and a potential attenuation of menopausal weight gain. The increase in the risk for gallstones, cholecystitis, and cholecystectomy seen with oral estrogen and estrogen-plus-progesterone therapy is reduced with transdermal hormone therapy.

Although some trials have suggested improvement in depressive symptoms in perimenopausal women taking hormone therapy, the overall evidence is not sufficient to recommend systemic therapy for the treatment of depression.

But even if hormone therapy does lead to improvements in mood, women are "more likely to experience a worsening of mood after estrogen withdrawal," Dr Pinkerton pointed out. Similarly, hormone therapy is not recommended for the treatment of dementia or cognitive decline at any age.

Despite the complexity of the data, women and clinicians have more options than ever when it comes to the type of hormone therapy they receive, the route of administration, and the dosing, Dr Pinkerton pointed out.

"This therapy can be individualized, and women who take it should not have to have a hard stop," Dr Pinkerton told Medscape Medical News. Older women and their providers should annually revisit whether to continue therapy. "Look at the woman, her risks, and what therapies are out there to determine how long to continue and what's safest for her to take."

Dr Pinkerton reports receiving research funds through the University of Virginia from TherapeuticsMD for clinical research. Dr Seibel has disclosed no relevant financial relationships.

North American Menopause Society (NAMS) 2017 Annual Meeting. Presented October 11, 2017.

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