JoAnn Pinkerton, M.D. is an OB-GYN who is on the board of trustees for the North American Menopause Society (NAMS). She completed time as president and vice president of NAMS in 2009 and 2010. In 2000, she took on the role of executive director, during which time she chaired the 2017 advisory panels for hormone therapy. More recently, Pinkerton served on the advisory panel for two recent position statements that NAMS put out, one on osteoporosis in 2021, and then the recent hormone therapy position statement that was released in July 2022.
Pinkerton, who is a membrer of HealthyWomen’s Women’s Health Advisory Council, spoke with Jaimie Seaton, our editor-in-chief about the new position statement from NAMS on the use of hormone therapy for menopause symptoms.
The transcript has been lightly edited for clarity and length.
HealthyWomen: Why did the North American Menopause Society feel it was necessary to issue a new position statement on hormone therapy at this time?
JoAnn Pinkerton, M.D.: The use of hormone therapy continues to be one of the most controversial and debated topics, so to further clarify the balance of risk and benefits of hormone therapy for menopausal women, NAMS wanted to review all of the new data on hormone therapy that was published after the last position statement in 2017. NAMS wanted to provide an up-to-date, scientifically accurate body of evidence about hormone therapy.
HealthyWomen: I know it's a complicated topic, but can you briefly describe what hormone therapy does and what the benefits are?
JoAnn Pinkerton, M.D.: When women go through menopause, they have a dramatic decline in their estrogen levels, primarily their hormone levels. Hormone therapy has been shown to be the most effective treatment for hot flashes, night sweats and sleep disturbance. It treats some of the vaginal changes and dryness and painful sex that can happen, and it's been shown to prevent bone loss and fracture. There are other benefits for some women, like improving mood or mental well-being. The most important thing is that the women who are most likely to benefit are women who have moderate to severe hot flashes or other symptoms of menopause, like low mood or sleep disruption, risk of bone loss or fracture, or those who have a very early menopause.
HealthyWomen: Can you briefly describe the questions around the use of hormone therapy and their origin?
JoAnn Pinkerton, M.D.: Before the Women's Health Initiative, hormone therapy was felt to benefit women across the ages to prevent heart disease and cognition at any age. And then the first Women’s Health Initiative was published in 2002 — and that was 20 years ago. Since that time, hormone therapy has been one of the most hotly debated topics around the treatment of bothersome menopause symptoms. Because what we learned initially was that there were risks seen in this trial of breast cancer, heart diseases, stroke, blood clots and probable dementia.
But then it turned out that the WHI really had too many women in the trial who were older when they started the therapy, between the ages of 60 and 79, and too few of the women between the ages of 50 and 59, who are the ones that are symptomatic from menopause and the ones we want to treat and for whom hormone therapy has the most benefit. What we learned was that the age of initiation of hormone therapy was the most important predictor of benefit or risk.
HealthyWomen: Can you briefly explain what’s in the new statement and if and how it differs from the 2017 statement?
JoAnn Pinkerton, M.D.: Well, the major conclusion of the 2022 statement is actually similar to the NAMS hormone therapy position statement in 2017. After an exhaustive research and review of the literature, hormone therapy remains the most effective, safe treatment for hot flashes, night sweats and vaginal changes and has been shown to prevent bone loss and fracture. And those benefits outweigh the risk for most healthy symptomatic women if they're under 60 or within 10 years of menopause. But we do believe you need to stratify risk by age and time since menopause, and that there is some benefit for some women of the transdermal [through the skin], non-oral roots and lower doses of hormone therapy to decrease some of the risks of blood clot and stroke.
When we first started hormone therapy, we only had oral hormone therapy pills. But now, we have many different ways of giving hormones. There are patches, gels, sprays and vaginal therapies, and those therapies bypass the liver, so there's less risk of blood clots and stroke.
When NAMS reviewed the additional information, they really strengthened the recommendations made in 2017 about age and time for menopause. And they clarified that, for select survivors of breast and endometrial cancer, there is data showing that low-dose vaginal estrogen therapy for women who aren’t helped by lubricants and moisturizers appears safe and improves quality of life.
HealthyWomen: In addition to what you’ve said, what do women need to know about the use of hormone therapy to ease menopause symptoms?
JoAnn Pinkerton, M.D.: In general, we want to minimize the amount and duration of use for the least risk. Women and their providers need to find the best product for them — could be oral patch, gel, cream, spray or just vaginal — and women may need to find menopause specialists to help them find the best and safest therapy. If women have their uterus, they need to take some type of progesterone to protect against endometrial or uterine cancers. And then lastly, I want to say that breast cancer risk doesn't increase appreciably with short-term use of estrogen, with or without progesterone therapy; it may actually be decreased with estrogen alone. The natural bioidentical progesterones that are available and are FDA-approved appear safer on the breast than some of the older synthetic progesterones.
HealthyWomen: Well, that leads perfectly into my next question which is, What health conditions or complications does hormone therapy protect against, if any?
JoAnn Pinkerton, M.D.: For menopausal women — beyond the relief of hot flashes, night sweats, improvement in sleep and mood — there may be additional benefits on the heart and brain when given around menopause, such as a lowered risk of diabetes, modest improvement in joint pains, less colon cancer, less brain fog, and then this unclear long-term benefit on brain. For women who have early menopause, we've shown that there are health benefits.
HealthyWomen: Are there any women who are not good candidates for hormone therapy?
JoAnn Pinkerton, M.D.: There are women who should consider non-hormone options. That's women who've had heart disease, such as a prior heart attack or stroke or blood clots, or if they have estrogen-sensitive cancers, such as breast or uterine cancer. If they have active liver disease or unexplained vaginal bleeding. We don't want to give estrogen if you have cancer or precancer or women who have migraine with aura because those women are at higher risk of stroke. And then lastly, women who don't want to take estrogen.
HealthyWomen: Are there any special considerations for women over the age of 60?
JoAnn Pinkerton, M.D.: There is a concern about starting hormone therapy after the age of 60, particularly after the age of 65 or 70, because there appears to be increased risk of heart issues, stroke and potentially, effects on the brain. But for women who want to continue it, who started it young and have persistent symptoms when they try to go off of it, there's really not good randomized controlled data about the risk and benefits, although there may be a potential rare risk of breast cancer with longer uses of hormone therapy. So for women who want to stay on it after 60, it can be considered if they have persistent hot flashes or bone loss or quality of life, but they need to be reevaluated every year because their health risk goes up as they age.
Hormone therapy doesn't have to be routinely discontinued. In women, age 60 or 65, you can consider them for continuation, but you really need an appropriate evaluation and counseling of benefits and risks. And there is this concern about increased risk of breast cancer with increased duration, longer-term uses.
HealthyWomen: Is there anything else we need to know? Is there anything I haven't asked you about that's important for you to make sure it gets across to the readers?
JoAnn Pinkerton, M.D.: I want to stress a couple points. One, women who have primary ovarian insufficiency or early menopause — whether from medical or chemotherapy or surgery — have a higher risk of bone loss, heart disease, and cognition and mood disorders associated with that loss of estrogen. And in general, it is recommended that these women take hormone therapy until at least the mean age of menopause, if there are no contraindications.
The second is, if women only have vaginal symptoms — vaginal dryness, pain with sex, urinary symptoms — they can consider just using vaginal estrogen or nonestrogen therapies. And also we can continue using vaginal estrogen for extended durations if needed.
Third, I mentioned this before, but I wanted to expound that compounded bioidentical hormone therapy that is made by pharmacists does have safety concerns because there's minimal government regulation and monitoring. And we have a concern about overdosing or underdosing the estrogen, the presence of impurities, lack of sterility, and just the lack of efficacy and safety data. And there's no label that tells you your risk. So if I give you a FDA-approved, even a vaginal estrogen, it lists all the risks. But if I give you a pellet [a dosage that is higher than is naturally present in the body], you don't get a label. And it's still the same type of hormones. It still has risks; even more because they're higher doses.
And then I do think that it's important that we look at dose and duration for women, and whether they should take it all or patch. There are so many options, and women need to find what's best for them.
And lastly, it's time to take the fear out of discussions and decisions about hormone therapy. I said this in 2017: Hormone therapy is still the most effective therapy. It's safe. We have lower doses. And women who have distressing hot flashes can have a conversation and feel comfortable considering hormone therapy. The data has been reviewed; the answers are the same.