What You Should Know About Treatment Guidelines With Hormone Therapy for Menopause
Hormone replacement therapy (HRT), more recently referred to as hormone therapy (HT), continues to percolate as a trending topic. Ongoing research regarding the safety profile of HT often places it in newspaper headlines or on national news programs. Celebrities like Suzanne Summers hawk versions of it on televised shopping networks. Finding trusted, clinically verified information can be challenging. And because women experience arange of complaints and levels of severity, up-to-date HT guidelines can help limit confusion.
The American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology released anupdated position statement on menopause in 2017. The American College of Gynecology (ACOG) regularly updates its position and treatment guidelines. The North America Menopause Society (NASM) also released a 2017 Position Statement Updates Guidelines for Hormone Therapy.
The AACE position statement is the first update since its 2011 clinical guidelines were released. It reviews new clinical studies and findings published since 2011 to support or update recommendations. The following are some features, highlights, and new recommendations (though many of the 2011 recommendations remain unchanged) included in the AACE 2017 position statement.
Specific recommendations in 2017 AACE position statement include:
Use of transdermal delivery system of the hormone as opposed to oral hormone therapy may be less likely to produce clots, the risk of stroke, or coronary artery disease.
If progesterone use is indicated, micronized delivery system may be safer.
In symptomatic postmenopausal patients (severe hot flashes, night sweats), who have a higher risk profile of negative outcomes from HT, use of selective serotonin re-uptake inhibitors (SSRIs) and other non-hormonal therapies may be safer, still effective options.
AACE does not recommend the use of bioidentical hormones in any case scenario.
HT is not recommended to prevent diabetes in postmenopausal women.
An individualized approach should be considered when treating patients with previously diagnosed diabetes, taking into account cardiac risk profile, age, and metabolic status.
The AACE reviewed several trials that were completed from 2011 to 2017. One of the studies, the KEEPS Trial, was a randomized controlled clinical trial. It looked at the possibility that there was a critical window of time during which the use of HT would not raise cardiac risk and might even limit risk of heart disease. The women in this trial were given oral conjugated estrogen (Premarin), transdermal estradiol (Climara), or placebo with micronized progesterone. The subjects, ages 42-58, were between six to 36 months post-menopausal, and all showed improvements in hot flashes, night sweats, bone density and sexual function during the short, four-year study.
To get a sense of how the three sets of guidelines (AACE, ACOG, and NASM) for menopausal treatment compare, I spoke to JoAnn V. Pinkerton, M.D., executive director of The North American Menopause Society, by email.
“NAMS found many benefits when hormone therapy is started at menopause, beyond just hot flashes, including improved sleep, mood, prevention of bone loss and vaginal changes, less diabetes, and less heart disease in women under age 60,” she said. “For women younger than 60 years or within 10 years of menopause onset, with no contraindications, those who will benefit the most are the women with bothersome hot flashes, night sweats, and sleep disruption and those at high risk of bone loss or fracture.”
She echoes experts in the field who suggest that there is no “one size fits all” protocol when it comes to deciding about hormone therapy:
“NAMS found that there are many newer hormone therapy options for menopausal women-lower doses, non-oral regimens (vaginal creams and suppositories), and regimens that don’t require progestogen, even in women with a uterus.Individualization is key.”
Where guidelines differ
Dr. Pinkerton highlighted one area where ACOG and NAMS guidelines are different. ACOG recommends that hormone therapy be prescribed only for the lowest dose and for the shortest period of time. The NAMS position is that this recommendation may “be inadequate or harmful for some women.” The NAMS 2017 Hormone Therapy Position Statement recommends “appropriate dose, duration, regimen and route of administration that provides the most benefit with the minimal amount of risk, with decisions made by clinicians on a case-by-case situation.”
NAMS also supports the use of HT beyond age 65 if unrelenting symptoms of menopause persist with ongoing, close surveillance and review of therapy and close monitoring to identify potential health risk.
Where guidelines are the same
Dr. Pinkerton pointed to additional ACOG updated guidelines that do agree with AACE and NAMS updated guidelines:
ACOG continues to recommend the lowest dose of hormone therapy for the shortest period of time for relief of hot flashes and menopausal symptoms.
ACOG recognizes that transdermal hormone therapy may be less pro-thrombotic, meaning less likely to cause blood clots and recommends individual decision making regarding oral or transdermal.
A recent ACOG committee opinion (2016) suggests that women with early endometrial cancer or breast cancer talk to their providers and oncologists if non-hormone therapies don’t relieve vaginal symptoms, as low dose vaginal therapy may be safe.
- It’s worth mentioning that ACEE recommends non-hormone therapies for women at the highest risk of developing complications associated with HT.
Dr. Pinkerton said that none of the three organizations support the use of HT at the time of menopause to prevent heart disease.
All major medical organizations — NAMS, ACOG, ACCE, the Endocrine Society, American Society for Reproductive Medicine, and International Menopause Society — recommend against the use of non-government approved compounded bioidentical therapies.
“Compounded hormone therapies, lack safety and efficacy data, are not monitored or regulated by the government, and have unique risks associated with compounding itself, including concerns about sterility; impurities; over- or under-dosing, which could increase cancer risk; and lack of a label providing warnings about potential risks,” she said.
What about potential breast cancer risk?
When asked about the link between use of HT and breast cancer risk, Dr. Pinkerton outlined a complex association: “For women under age 60 or those within 10 years of menopause, the risk of breast cancer was rare ( <1/1000) with conjugated estrogen combined with progestin, as seen in the Women’s Health Initiative (WHI) study between 3-5 years of use.”
“However, fewer cases of breast cancer were seen in women who received conjugated estrogen alone compared to those randomized to placebo,” she said. “Micronized progesterone appears to have less risk of breast cancer in observational studies. The new product, conjugated estrogen with an estrogen agonist/antagonist (Bazedoxefine), appears neutral on the breast in studies up to two years. Longer duration of estrogen use by itself may increase the risk of breast cancer, but may take 15 or 20 years to be significantly different from nonuse.”
Some final thoughts
Research will continue to look at the possible link that HT has with risk of breast cancer and other conditions. Treatment guidelines will likely be modified as new information becomes available.
It’s important to have a conversation with your gynecologist about the benefits and risks associated with the many menopause therapies available to treat mild, moderate, or more severe post-menopausal symptoms.
The best plan is to create a personalized plan with your doctor that takes into account your age, symptoms, and risk factors.
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