Speaking of Women's Health
The Speaking of Women's Health Podcast is excited to bring you credible women's health information from host and Executive Director, Dr. Holly L. Thacker. Dr. Thacker will interview guest clinicians discussing relevant women's health topics and the latest news and tips.
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Speaking of Women's Health
Hormone Therapy After 65: Discover the Truth and Benefits
Join Host Dr. Holly Thacker as she discusses the groundbreaking study from the Journal of Medicine involving over 10 million American women aged 65 and older. Despite Medicare’s recommendations, this study shows that initiating systemic hormone therapy within a decade of menopause can lead to remarkable health benefits, including lower mortality rates.
She highlights significant findings that reveal reductions in mortality and breast cancer among women who use estrogen, and discuss the varied impacts of different estrogen forms on health risks.
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Welcome to the Speaking of Women's Health podcast. I'm your host, Dr Holly Thacker, and I'm back in the Sunflower House for a brand new edition of the Speaking of Women's Health podcast.
Speaker 2:And the topic we're going to go over today is actually a very important publication in the Journal of Medicine. It is a blockbuster. It's a study of 10 million actually over 10 million United States, american women over age 65, and their use of various types of hormone therapy and the medical claims made to Medicare, our government. They have all the data. I'm actually a little bit surprised that this was published, because Medicare really discourages the use of hormone therapy in women over 65. And I've talked about this in other podcasts.
Speaker 2:In fact, you get nasty letters as a prescribing physician if you have more than 7% of your females age 65 and older on hormone therapy and I've always kind of joked is this just because they don't want their beneficiaries to live longer? Because we certainly have known for quite a long time that women who take hormone therapy systemically under the age of 65, within 10 years of menopause, live longer and die from all causes in general less often, even though that's not the general urban gestalt. So the thoughts were basically well, if you're already past this critical time period of 10 years from losing your estrogen, that maybe some of the preventive benefits on the brain and the cardiovascular system wouldn't be as great. Now we've known for a long time that if you give local estrogen at any age, that is going to help the vaginal atrophy, the so-called genitourinary syndrome of menopause, which is a much better term because it encompasses overactive bladder, bladder irritation, recurrent bladder infections. All these things are made worse when a woman loses the sex hormones and that tissue, which is very sensitive to the sex hormones, dramatically drops. And even standard or low dose systemic menopausal hormone therapy may not be quite enough for the urogenital tissue tissue.
Speaker 2:So this study looked at beneficiaries that were in the medical database for 13 years, from 2007 to 2020. And, as you'll recall, the Women's Health Initiative the largest expensive preventive health trial, randomized controlled trial in older women, primarily average age 63, 64, was published. The first series July of 2002, which was just a few months after I opened up the Center for Specialized Women's Health, and all the headlines you know caused panic, caused millions of women to throw away their prescriptions and really had a terrible, terrible fallout. When they finally released the age stratified data, we found out that women who had taken hormones had lower death rates, particularly if they started within 10 years of menopause. So this particular study and the authors were a PhD, c-o-b-a-i-k and a physician by the name of Clement McDonald and a master's in science, fitzsum Bay, and so they published this in April of 2024. And we have this study actually summarized and bookmarked on our Speaking of Women's Health website. So if you don't have that marked on our Speaking of Women's Health website, so if you don't have that bookmarked speakingofwomenshealthcom under the dropdown under news, you'll see us post this study and the implications.
Speaker 2:Of this is very important because we do have a lot of women over age 65 who want advice and counseling and unfortunately, most physicians, nurse practitioners, prescribers, physician assistants will frequently say oh, over 65, you should just stop. I mean, they discourage a lot of times inappropriately women under age 65 from not taking hormone therapy. So this is really very disappointing. In fact, I just saw a lady today in the office and I followed her for years for perimenopause, got her situated with a menopausal treatment doing well on low dose hormone therapy. Her bone density was improved, her symptoms were controlled, she had no side effects and she still required a little bit of local estrogen because the systemic dose was pretty low. We tend to lower the dose after age 65.
Speaker 2:And she just said well, I wonder if I'm supposed to come off of it now. And I'm like this is someone that I've seen and reevaluated and given our access to the latest information, which has constantly reinforced that you do want to treat estrogen deficiency. And I said, well, you're not going to spontaneously make estrogen again and you can certainly go off treatment, but then we will definitely have to use something to treat the osteoporosis which actually had improved osteopenia, and you may have to actually use more local treatment for your vagina and bladder. And I said what's different? What's making you think Are you having side effects or problems or is it an expense issue? And she just remarked well, my primary care doctor said I should get off of it. I'm like, yeah, because your primary care doctor probably doesn't want to get you know letters saying you know, don't prescribe this. This is considered high risk based on really old criteria, the old beer criteria. So I hope this study is used to change recommendations. But if it's like anything else, like the box warnings on vaginal estrogen, which shouldn't be there, still are there and people have been working on that for a long time.
Speaker 2:So whatever large governmental alphabet agencies say isn't really always the latest and greatest, and so that's why, in order to keep you strong and healthy and in charge. We want to bring you the latest information in health, wellness and certainly working to dispel these myths and misunderstandings. So after July of 2022, all the pharmacy database records saw huge plummeting of hormone therapy and it's disappointing because women still were entering menopause and they still were estrogen deficient. Many of them had hot flashes, many of them lost bone, many of them had other menopausal symptoms. You know that can range from all sorts of things, from hair thinning to to poor sleep, to brain fog and and we've covered a lot of these topics in depth in a prior podcast we have well over a hundred podcasts now, and so people that are new to this you might want to take some time to scroll back over prior topics. You can also go on the website speakinginwomenshealthcom and just put in a topic you're interested in space podcast and then search and it should bring up podcasts on that topic.
Speaker 2:So the WHI was really devastating for a generation of women, and that's because overall health outcomes are better in women who are not hormonally deficient and risk for mortality, certain cancers and cardiovascular outcomes. In this study of women, it was not a randomized controlled trial. In this study of women, it was not a randomized controlled trial. It looked at all women in the database and obviously it looked at just what prescription they were on and what the list of diagnoses were and um, but it's powerful because there's so much data and the information on diagnosis and claims and prescriptions. You know it's not 100% accurate but it's about as accurate as you can get looking at medical records vaginal progesterone, natural, oral synthetic progestin and also just women who only use local vaginal treatments. And they looked at several different outcomes.
Speaker 2:And it's important to note that age doesn't necessarily make hot flashes go away and you can be five years, 10 years, even 20 or 30 years past your final, last menstrual period, which is generally the time that you enter into menopause, which is a retrospective diagnosis. Symptoms don't go away and the bone loss which occurs to half of women continues and the genitourinary symptoms can continue over time. I think I'll post on my website with a link in the show notes from the book that I wrote, the Cleveland Clinic Guide to Menopause. I have a slide that looks at estrogen levels and then onset of disease and when it comes on, and looking at that, because I wrote this several years ago the book and then I updated it when I podcasted my book at the beginning of last season in 2023, the Cleveland Clinic Guide to Menopause, I noted that we just talked about the classic areas of what happens after menopause Half a woman have hot flashes, half a woman lose bone and about 80% can have some genitourinary symptoms. I didn't include other things like general longevity or cardiovascular outcomes or cancer outcomes, dementia, which, of course, is a big concern for the 65 plus crowd, because one in two women have dementia by age 85. Um, but the ones that really aren't disputed and that are clearly linked and that generally um, stabilize or get better in the vast majority of women, kind of stuck to that. So there were 10.9 million women that were looked at.
Speaker 2:They looked at the prescription, drugs, the medical records and they got the data from the Centers of Medicare and Medicaid Services CMS, medicare and Medicaid services, cms and the health outcomes they looked at and they looked at, as I mentioned, estrogen, progesterone, progestin, as well as the doses and strengths and what the route of administration. And they looked at all-cause mortality, because that is the most inarguable bad outcome basically that you could have, which would be death and it's not really disputed. You're either alive or you're dead, and if you're dead, you're not making any more claims for Medicare. They also looked at cancers that women are very concerned about, such as breast cancer, ovarian cancer. Looked at cancers that women are very concerned about, such as breast cancer, ovarian cancer, endometrial uterine cancer, as well as lung cancer and colorectal cancer, and colorectal cancer is really rising in younger people.
Speaker 2:Heart disease, the number one cause of death in women, was looked at, with breakdowns of congestive heart failure, myocardial infarction, which is a heart attack, or MI, and, of course, um, afib, which is more common in women over 65, and then the dreaded dementia uh, senile dementia of the Alzheimer's type. So only 14% of women over age 65 during this time period from 2007 to 2020 used any type of hormone therapy and, furthermore, the percent of women age 65 and older using any hormone therapy declined from 11.4 percent at the beginning of the study to only 5.5 percent in 2020. And in the late 20 teens, we already had the mortality data with the Women's Health Initiative. So I think that's really extremely unfortunate that the numbers of use has kept decreasing, and death incidence in this study was much lower among women who used any type of hormone therapy compared to those who used none, which, of course, was the majority of women, and we're talking about 6.3 deaths per thousand women, even though you can't have a third of a person die. But you know, it's the statistics compared to the baseline in non-hormone users of 12.6. So that's a significant difference.
Speaker 2:Now, of course, socioeconomic status and health status comorbid diseases were not randomized, but observational data is very important and randomized controlled trials are not the end all be all, and we certainly found that in the Women's Health Initiative, because even when you randomize women to get placebo or hormone therapy, if the person has hot flashes, they're going to know if they're on the placebo because they're not going to really have improvement in their symptoms, or only the placebo effect versus those women on hormone therapy effect versus those women on hormone therapy. Now, what they did do to try to get a gauge on socioeconomic status was looking at Medicaid eligibility from a special supplement as a proxy for income, because for years it's been argued that women with better socioeconomic status, higher education levels, take better care of themselves, know more about health, can visit the physician or healthcare facility more often. And is this just a proxy marker? But, given that we've got this huge, huge database and there's several interesting tables in the study and it looked at, you know, the age comparisons on hormone therapy versus not hormone therapy percentage of whites, blacks, hispanics, asian, and it looked at so many different whether they lived in an urban area or rural area, based on their zip code, whether they had ever had a pulmonary embolus, blood clot in the lungs or atrial fibrillation or heart failure or stroke cataracts. So, of course, like, for instance, a lot of people over 65 have cataracts. If you haven't heard the podcast on cataracts I did earlier, that would be a good one to listen to. So almost 68% of the women who took hormones had cataracts and that compared to like 52% of women that hadn't taken any hormones. So again, there's like high burdens of diseases in kind of both groups and most of it's really pretty pretty equivalent heart failure, depression, the baseline or diagnoses of any dementia, osteoporosis, rheumatoid arthritis, colorectal cancer, ovarian cancer, anemia, asthma, high cholesterol, high blood pressure, alcohol use disorder, bipolar drug use, personality disorder, schizophrenia and other psychotic conditions. So it was like 1.8% in both groups.
Speaker 2:Just as an example, epilepsy. You know estrogen can simulate the brain. I would have thought maybe less women with epilepsy would be on hormone therapy in this group older than 65. And it was again 2% equal in both groups Hepatitis, liver disease, mobility impairments from arthritis, obesity, tobacco use. So you can see and I haven't even named all the conditions, but those were all the codes that they looked at and the bottom line.
Speaker 2:And before I get to the bottom line, just to remind you, you're listening to the Speaking of Women's Health podcast and I'm your host, dr Holly Thacker. We're in the second season, 2024, talking about this blockbuster study of over 10 million United States women over 65. And the bottom line of this study, which looked at 13 years of data of US older women, that vaginal estrogen, transdermal hormone therapy and oral estrogen therapy were all associated with reductions in mortality risk 30% if they were on vaginal, 20% if they were on transdermal and 11% on the oral estrogen. Now that doesn't mean that only vaginal is better. And certainly we know from the randomized controlled trial of the Women's Health Initiative that estrogen alone in women with a hysterectomy reduces breast cancer well into the 70s. We also know that women that are likely just to be on estrogen systemically are most likely not women that have a uterus, because you have to protect the uterus and give a woman progesterone or progestin. And also, from what I see is that during this time period, because of pharmacy benefit managers and drug pricing and I go into that quite a bit on my podcast on how to save money on medicine and you can also read the article that has lots of great links Vaginal estrogen even though it's been around for decades, sometimes insurances and Medicare are trying to charge women like $500 for a little tube.
Speaker 2:So to be on vaginal estrogen. I wondered if it's a little bit more of a proxy for being extremely motivated, maybe in an intimate relationship, maybe a little more socioeconomic status. Seeing that there was more mortality reduction with lower doses in transdermal kind of goes along with our concerns about oral estrogen in a higher dose after 65 is known to increase the risk of stroke one extra case per thousand women but because the women in all the groups in general did better and had much less burden of disease, this has changed my practice in that I'm a little bit more flexible and not so rigid about. You need to reduce the dose. We need to do transdermal, because there are some women, based on their personal circumstances, their finances, their lifestyle, who really prefer one type of treatment over another, and so it's really not one size fits all I mean menopausal medicine is easy in that you don't want hormonal deficiency, but it's very nuanced in terms of what's the best, most individualized, appropriate regimen for a woman. And when these authors looked at women who had used estrogen and compared it to those who had never used estrogen or who had stopped it, and looked at reductions in death rates and reductions in several cancers and heart problems, it's very impressive. Now, generally speaking, the lower doses, along with transdermal and vaginal preparations, had somewhat better risk profiles. So that does kind of generally reinforce guidelines. So that does kind of generally reinforce guidelines.
Speaker 2:We saw a 19% mortality, adjusted hazard rate, which was 0.81, 16% reduction for breast cancer, 13% reduction of lung cancer so that was very interesting. Had a tight confidence interval 12% reduction for colorectal cancer% reduction for conjunctive heart failure. That surprised me. I would have thought that would have been a little better. And, interestingly, a 3% reduction for venous thromboembolism. I mean I have seen women who had a provoked blood clot have physicians say, oh, you can't be on any hormones ever. And the DOPS study, the Danish osteoporosis study, which was for 10 years and gave oral estrogen and oral progestin granted it was to women under age 65, that showed reductions in deep venous thrombosis. So you know we can't be so absolute. There was 4% less atrial fibrillation and, importantly, 11% reduction in acute MI and only 2% reduction for dementia. And I think with the brain, even though we're learning new things about estrogen receptors in the brain dramatically increasing in post-menopause and maybe the window of brain benefit may be greater.
Speaker 2:So I'm not an absolutist. I really try to diagnose the age of menopause historically, hormonally and menstrually and they're not always exactly the same. And some women are in menopause but they're not really hormonally deficient because their ovaries and their adrenal glands make enough hormones. Their metabolism is such that they really don't get into deficiency symptoms till later. So I'm not so strict always about the years. I would certainly prefer to start hormone therapy within 10 years, if not six years, of menopause. But there's really no absolutes and certainly in women who don't want systemic hormones maybe they don't have hot flashes, they don't want to take anything If they do need something for vaginal atrophy I'm more likely to want to pick a vaginal estrogen these days as opposed to vaginal DHEA, which is so excellent because it doesn't affect the uterus.
Speaker 2:It boosts estrogen and testosterone. We use it for because it doesn't affect the uterus. It boosts estrogen and testosterone. We use it for low sex drive. It's less expensive Usually not always the commercial one can be more expensive, depending. But we can compound a slightly higher percent and still be compliant with the federal law and that research shows the higher percent 1% is better for climax and sexual function. But especially if a woman doesn't have a uterus or endometrium, then I would really generally favor vaginal estrogen and the Women's Health Initiative showed that vaginal estrogen, compared to those who weren't on it and weren't on systemic hormones, had better outcomes. So it's really ridiculous to have any boxed warning on vaginal estrogen products, like they have for heart attack and so forth.
Speaker 2:Now, looking at conjugated equine estrogens, of which the brand name is Premarin, comes in lots of different doses. 0.625 is the maroonish brown tablet. That's kind of the standard. My whole career I've always seen a decent subset of women who've taken Premarin versus transdermal bioidentical estrogen and there's something in it that they feel better. It's like more of a kick and there's 10 different estrogens and it's not directly comparable to just plain estradiol orally or by patch. And there was a 23% reduced risk of breast cancer diagnosis, while the so-called bioidentical estradiol showed the 12% reduction. So less so when I see women at high risk for breast cancer or breast cancer survivors. If I'm not worried about high triglycerides or blood clot and they're specifically very concerned about their breast.
Speaker 2:I generally prefer oral conjugated estrogens and I know that there was a big mantra for a long time that oh, it's just safer if you use transdermal and in some cases it may be marginally better. But I don't think we can be so absolute Now, interestingly, there were women getting injectable estrogens, which that would be high dose, and I'm not sure why anybody was doing that, but apparently there are people doing that, so they had them in their database and they did show an increased risk of heart disease with high dose. Injectables and also oral estrogens increased the risk of stroke by 8% and dementia by 3% and probably the memory loss in women over age 65 in the MIM study, the memory study that was an offshoot of the Women's Health Initiative. If you increase the risk of stroke and pick off parts of the brain, obviously there's going to be more cognitive decline. So in women at high risk for stroke, uncontrolled hypertension, atrial fibrillation, smoking, diabetes, known carotid atherosclerosis these would all be indications to use lower doses or transdermal.
Speaker 2:But I have plenty of healthy women who are 70, 80, and 90, and they want their oral estrogen and Premarin and they've done well on it and so it's an option. I mean, we have to sometimes take this hubris as if we think we know everything when we don't. It's so important to listen to the patient. In the study, overall, the use of estrogen alone was 10 times greater than estrogen, progestin or only progesterone alone, and twice as many women were on vaginal estrogen than systemic. And that's again not surprising because so many women are just pulled off of it and told they can't take it. Now half of the women who had hysterectomies also had their ovaries and tubes out, so that reduces breast cancer. When you take out the ovaries, when you take out the tubes and ovaries, that also reduces ovarian cancer, so that's an important thing to note.
Speaker 2:It's not just the fact that they're taking estrogen therapy why they have a reduced ovarian cancer, but the Women's Health Initiative looked at data prospectively in the randomized control trial with ovarian cancer and the article in fact I know I did a summary on it on speaking of women's health years ago it was published in the Journal of the American Medical Association and the data showed no difference in ovarian cancer on hormone therapy or not. But the conclusion, which is what a lot of people just read, or the news, people who run with their little headlines, kind of non-scientific little tidbits to get people's attention for clickbait or attention on the news said, well it may, okay, well, that's not what it showed. Now, conjugated equine estrogens in the Women's Health Initiative was associated with a 6% mortality reduction in that 18 years of follow-up, and so that gives complete plausibility to the 9% reduction that was seen in this older group of 65 plus women with the use of medium dose oral estradiol and um. Medium dose would be 0.625. And I do have women who don't want to reduce from that 0.625 after age 65. And I know some of you are listening and know that I'm talking about you, even though of course, I'm not going to at all use anyone's name. It's just the point that we individualize uh therapy and and women should have choices. Now, the 19% reduction in death rate with estrogen therapy is completely consistent with over 30 observational studies as well as randomized controlled trials that we've had, including WHI and the Danish osteoporosis study Study also a large database from Kaiser that have shown reduced death rates in users of hormone therapy.
Speaker 2:Now, looking at the women who used estrogen plus progestin, they had a 45% reduction for endometrial cancer. So if you're on a progestin, it generally means you have a uterus. So if you're on a progestin, it generally means you have a uterus, and taking nothing at all versus estrogen plus progestin reduces uterine cancer. There was, interestingly, a 21% reduction in ovarian cancer, with a tight confidence interval 5% reduction for ischemic heart disease, 5% for congestive heart failure and, interestingly, 5% for venous thromboembolism. And the women who just use estrogen with natural progesterone, which people have promoted a lot of naturopaths and functional medicine people and alternative people or people who you know we're thinking oh, it's just the synthetic progestin or it's just the conjugated estrogen. That's the problem in the WHI, which I never said and I haven't moved from that. I just simply looked at the data and, interestingly, estrogen plus natural progesterone did show just a 4% reduction for congestive heart failure.
Speaker 2:And estrogen plus progesterone therapy, though, regardless of whether it was synthetic or natural, didn't show reductions in mortality. And so to me, if you don't need progesterone and you don't have a uterus, then there's got to be a pretty darn good reason to add progesterone, like very, you know, some anxious women, some women who don't sleep very well, like the natural progesterone, some women with seizures, but for the most part, if you don't have a uterus or endometrium you should, you don't need the progesterone. Um, and in this study of women over 65, whether women used estrogen with a synthetic progestin or estrogen with a natural progesterone, it was still was still associated with an increased risk of being diagnosed with breast cancer by 10 to 19%. So a lot of people say, oh, natural progesterone is better for the breast. Well, I don't think we really have that evidence. Progestin stimulates the breast, but mortality is the most important outcome, as well as quality of life.
Speaker 2:Now, because hormone therapy, even though it has lots of preventive benefits, it's not 100% preventive Anything that might have a side effect or stimulate the breast or the uterus or blood clot. You know women are perfectly within their realm if they're comfortable and they're checking their bone and they're taking care of their vagina and they've been counseled on the risk, benefits and alternatives. There's plenty of women over 65 who don't need hormone therapy and there's still a lot we don't understand about remaining ovarian function. We know there's cardiovascular benefit to keeping your ovaries in general to age 65, unless you carry a genetic mutation and not everybody's wired the same, not everybody has the same metabolism. But I think what we do know if you're suffering with symptoms and you have areas that you might want treatment and potentially preventive, then the package and the options that you have with local, systemic, high-dose, high dose, low dose hormone therapy is really quite a quite a bargain medically speaking.
Speaker 2:Interestingly, they had some women who were just on plain natural progesterone and that had a 22 percent reduction in mortality and a 19% reduction of risk for lung cancer and just progesterone naturally alone, a 10% reduced risk for breast cancer diagnosis. So, but synthetic progestins only and I suspect maybe those were women who might've had bleeding or endometrial hyperplasia. So maybe it's a marker for obesity, because those are the only women I can think of over age 65 who would only be on a synthetic progestin, had an 11% increased risk for mortality, 21% increased risk of breast cancer diagnosis and 14% increased risk for lung cancer diagnosis. And I think that that could be a marker for body mass index and obesity, because certainly obesity increases death rates, it increases cancer risk. You know insulin resistance increases lots of different problems. So overall, taking a certain therapy or prescription, it's not a cause and effect. But looking at these associations and seeing that you have a 30% or 20% or 11% reductions in death rates in women on these different types of hormone therapy to me is extremely reassuring for women who want or need hormone therapy to me is extremely reassuring for women who want or need hormone therapy. And denying hormone therapy really, especially local vaginal estrogen, is completely ageist and completely sexist and it's really against our motto of be strong, be healthy and be in charge.
Speaker 2:Now I have published an official review or column on speakingwomenshealthcom and we have a lot of additional resources my book, which is podcasted. Of course, I podcasted and updated that book before we had the study, but most of what I say is completely consistent. I did a review a few years ago on the 20th anniversary of the Women's Health Initiative. I did a pretty pointed review called what Does Menopausal Hormone Therapy have to Do with Politics? Are the Women's Health Investigators Collectivist? Well, some of them are something or other, because a few of them certainly have recanted or have been honest about the data and haven't been fear mongering, but for a long time the NIH perspective was very anti-hormone.
Speaker 2:I did a column on new women's health analysis. This time estrogen saves lives, which of course it did. They just took a while to get us the data Did a column on in the latest report from the Women's Health Initiative. The data contradict the conclusions. That was the one on ovarian cancer. Also, we published a link to a scientific study that I did with some colleagues on a case study of risk and effectiveness of compounded bioidentical hormones.
Speaker 2:That was all the rage after the Women's Health Initiative because women still were hormone deficient but they were terrified of prescription hormones. And certainly unregulated hormones are way riskier than getting prescription hormones, even high dose prescription hormones, even if you're over 65. And now the latest rage, unfortunately and I think a lot of it's driven by finances is pellets of giving women male levels of testosterone. And when you get that rush of testosterone, yes, you're going to feel like you can take on the world and you've got energy and you're interested in sex. But long term that's not natural, that's not the female state and not all women. But many women get punished with androgenic side effects of, you know, androgenic hair thinning, chin whiskers, deepening of the voice, irritability, acne, weight gain. You know, testosterone puts on muscle and can put on weight. So go running the other direction if somebody is trying to sell you a pellet please.
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