Decoding MHT Menopause Hormone Therapy Myths & Facts

[00:00:02] Introduction to the Podcast

[00:00:02] Welcome to Pause to Go, the podcast that's all about making the most of life's transitions from middle school through menopause. I'm your host, Brie Luck, joining you as we embark on a journey of self discovery and questionable decisions. Get ready for heartfelt conversations, expert insights, and personal stories that'll have you laughing, crying, and saying, thank goodness I'm not alone.

[00:00:30] If you've lost your midlife crisis survival kit, we've got you covered. So join me, won't you? And together, we can pause to go.

[00:00:44] Bree:

[00:00:44] The History of Women in Clinical Research

[00:00:44] Bree: Today, we are diving into a topic that's really crucial and important for all of us. And that is the history of women and people with uteruses and ovaries in clinical research. [00:01:00] So you may know it wasn't until the 1990s that people who are clinically identified as female started to be regularly included in clinical studies.

[00:01:12] Bree: Can you believe that? So let's unpack why that was, how things finally began to change, and the effect that that has had on menopausal hormone therapy and what the current studies show about the efficacy and risks involved with menopausal hormone therapy. In this episode, I will refer often to people as women because that's how they were referred to in those studies or in the articles, but let's generally assume that that means people who were clinically identified as female at birth and then then.

[00:01:57] Bree: We're also going to talk [00:02:00] about hormone replacement therapy and menopausal hormone therapy. I've talked about this in other episodes too. Currently, we like to use the term menopausal hormone therapy, but for many, many years it was referred to as HRT or hormone replacement therapy. So I may use them interchangeably in this episode,

[00:02:23] Bree: also, before we begin, I want to remind you that I am not a doctor, I am not a health care professional, I am not an expert on menopause or on hormones. I am simply a paramenopausal podcaster trying to sort this stuff out.

[00:02:40] A Shoutout to Supporters

[00:02:40] Bree: But before we jump in... I'd like to give a quick shout out to all of you amazing folks who have been so supportive of the Pause To Go podcast on Buy Me A Coffee.

[00:02:52] Bree: Your generosity keeps the caffeine flowing and these thought provoking discussions alive. [00:03:00] So if you love what you're hearing, or you are intrigued by it and want to fuel more insightful episodes of pause to go, just click on the buy me a coffee link in the show notes because nothing like caffeine to keep a podcast going. So.

[00:03:21] The Women's Health Movement in the 70s

[00:03:21] Bree: We're going to take a little stroll down memory lane and go back to the 70s, during the women's health movement. During this time, there was really a growing realization that women were largely absent from the medical and scientific fields.

[00:03:40] Bree: Most of the doctors, most of the researchers were male. And guess what? Our health needs were pretty much an afterthought. It was like we were invisible in the research that was shaping healthcare for everyone. But then it gets a little bit interesting in the late 70s. So in [00:04:00] 1977, the FDA, those are the folks who approve our meds, they put out this policy and it said, hey, We want to keep people who could potentially have babies away from early drug trials.

[00:04:16] Bree: Now, this was largely due to something called the thalidomide disaster. So thalidomide was a sedative that was never actually approved for use in the United States. However, the drug was widely used throughout Europe and Canada. And the thousands of women who took the drug while they were pregnant gave birth to babies with pretty significant deformities.

[00:04:44] Bree: So, in a way, the FDA was making a protective move, but when they decided to exclude people who had any potential of bearing children from drug trials, the policy was very broad, [00:05:00] and it recommended excluding even women who use contraception and women who were single or whose husbands were vasectomized.

[00:05:10] Bree: And this meant that we had little to no data on how a lot of drugs affected women.

[00:05:17] The Fight for Inclusion in Clinical Trials

[00:05:17] Bree: Now, after some years, people started to question this, and they were asking, why can't women decide for themselves if they want to participate in research? And activists, especially around the HIV drug trials, really pushed back.

[00:05:32] Bree: They said, hey, include us! We deserve to know how these drugs work on our bodies, too. And you know what? They were right. And by 1986, the NIH started nudging researchers to, you know, include women in their studies. Progress? Maybe. But here's a twist. Even though the NIH said, hey, let's include women, it wasn't really [00:06:00] enforced.

[00:06:01] Bree:

[00:06:01] The Impact of the NIH Revitalization Act of 1993

[00:06:01] Bree: In 1990, the Office of Research on Women's Health was established, but it took another three years for Congress to pass federal law through a section in the NIH revitalization act of 1993.

[00:06:17] Bree: And for all of you legal folks out there, that's public law. 103 43 titled Women and Minorities as Subjects in Clinical Research. So this law, was a game changer. In layperson's terms, it basically said, from now on, you've got to include women and minorities in all NIH funded research. And researchers said, Oh, it's so expensive.

[00:06:47] Bree: We don't want to include women because hormones, babies, period, stress, socioeconomic discrepancies, they bring on so many more variables. Let's face it, white males are [00:07:00] just so much simpler and cheaper to study. But the NIH said, Nope, no excuses, not at all. Not even money. And just like that, women and minorities were no longer on the sidelines of medical research.

[00:07:16] Bree: Took them long enough. By September 1994, which I don't know about you, but I was 21 years old then, it was official. The NIH would not fund any grant, cooperative agreement or contract, or support any intramural project unless it complied with this policy. Further, every year grantees have to report on the sex, race, and ethnicity of the people who are enrolled in all of the clinical trials covered by this policy.

[00:07:50] Bree: And since 1994, the NIH has published reports about the activities, including the results and accomplishments of [00:08:00] NIH supported research. So they've been keeping tabs on who's included in these studies. I will tell you, I tried to go and look up these reports, but I could not attain access on the NIH website.

[00:08:16] Bree: So, seems like they aren't really all that public. But, This reporting, this law isn't just about fairness. It's about getting accurate, life saving data that reflects all of us.

[00:08:32] The Journey from Exclusion to Inclusion

[00:08:32] Bree: So there you have it, a journey from exclusion to inclusion in medical research.

[00:08:37] Bree: It's a reminder of how far we've come and how vital it is to be seen and heard in every aspect of healthcare. As we dive deeper into our main topic today, keep this history in mind because it really plays a key role in understanding and advocating for our health.

[00:08:59] A Look Back at Hormone Herstory

[00:08:59] Bree: [00:09:00] So now we're going to go back and look at some hormone herstory. We're going to look back at when we first started to understand the impact of decreased hormone production during menopause. So in the early 20th century, we had a feeling that menopause brought on hot flashes, but it was in the early 1940s that the FDA approved the first estrogen product, Premarin, for hot flashes.

[00:09:31]

[00:09:31] Bree: Premarin was isolated from pregnant mares.

[00:09:35] The Controversy Surrounding Hormone Replacement Therapy

[00:09:35] Bree: It was a pretty complex mixture containing more than 50 estrogens, and it was used as a treatment for hot flashes, osteoporosis, and other symptoms of menopause, then we moved into the 1960s and in the 60s, the feminist movement was in full swing, And there's this book, Feminine [00:10:00] Forever. It was written by the Brooklyn gynecologist, Robert A.

[00:10:03] Bree: Wilson. And he posited that menopause, and it really pains me to say this, by the way, menopause was an estrogen deficiency disease that should be treated with estrogen replacement therapy to prevent the otherwise inevitable, and I quote this, living decay. End quote. I gotta tell you, there are some notable pulls from this book that truly make me sick.

[00:10:38] Bree: Things like, this one. Every woman alive today has the option of remaining feminine forever. No longer need she fret about the cruel irony of women aging faster than men. It is simply no longer true that the sexuality of a woman past 40 necessarily declines more [00:11:00] rapidly than that of her husband. Oh, here's another one.

[00:11:06] Bree: All postmenopausal women are castrates. Oh, he continues to say that with HRT, a woman's, quote, Breasts and genital organs will not shrivel. She will be much more pleasant to live with and will not become dull and unattractive. End quote. Despite all of this, or maybe, unfortunately, because of it. The book's a hit, and suddenly everyone's on Premarin, and doctors are prescribing Premarin left and right.

[00:11:42] My grandmother was on it. She swore by it. She loved it, and she lived to be 98, so it worked for her. But with all good stories, there is a plot twist. And in the 70s, there was a study and by the way, [00:12:00] references for these studies are in the show notes. And that study suggested that estrogen alone could increase the risk of endometrial cancer.

[00:12:11] Bree: So that wasn't great news for HRT's reputation, right? But money, I mean, science, always finds a way. And researchers discovered that adding progesterone to estrogen reduced this risk. This combo therapy of estrogen and progesterone or progestogens became the go to for people with a uterus, reigniting the excitement for hormone therapy.

[00:12:37] Bree: Initially, hormone therapy was really about treating hot flashes, but in 1988, it got the FDA's nod for preventing osteoporosis too. And then, studies started hinting that hormone therapy wasn't just about staying feminine forever, but also [00:13:00] healthy. So now you're speaking my language. It seemed like it might help with more than just menopausal side effects, but that it might also help with chronic disease prevention.

[00:13:16] Bree: But with great promise comes great scrutiny, and the FDA wanted hard evidence of hormone therapy's heart benefits. So this led to some big studies.

[00:13:27] The Women's Health Initiative and Its Impact

[00:13:27] Bree: and then there was a really big one the women's health initiative This was huge folks. It looked at hormones therapies effects on heart disease Cancer you name it.

[00:13:40] Bree: This was a 725 million dollar study and it was truly intended to resolve the controversy over When or whether menopause should be embraced as a natural transition in life or if menopause was in fact a hormone [00:14:00] deficiency that was totally preventable with hormone therapy. So this began in 1991 and it was a proposed 15 year study and people in menopause with a uterus were randomized to take orally either a placebo or Prempro, which was a combination of Premarin and a synthetic version of progesterone.

[00:14:29] Bree: And women with a hysterectomy were either given Premarin alone or a placebo. But in 2002, they had to hit the brakes on the women's health initiative. In fact, the entire study was abruptly stopped due to a statistical increase in breast cancer and stroke and no apparent benefit for reducing cardiovascular risk.

[00:14:58] Bree: I mean... [00:15:00] The risks truly seem to outweigh the benefits here. And let me tell you, panic ensued. Hormone prescriptions plummeted and guidelines changed overnight. But here's the thing, that trial had some major gaps. It was pretty problematic. For one thing, most participants were in their 60s. That's well past the typical onset of menopause.

[00:15:29] Bree: And they only tested one type of hormone therapy, Premarin. This left a lot of questions unanswered, especially for younger paramenopausal or recently menopausal people. So what's the takeaway here? Research can be a game changer time and time again, but it's not always perfect. It evolves just like our understanding of health.

[00:15:56] Bree: And that's why we have to keep digging, keep questioning, [00:16:00] and most importantly, keep learning.

[00:16:02] The Current State of Menopausal Hormone Therapy

[00:16:02] Bree: So let's dive into the here and now of menopausal hormone therapy. There has been a lot of buzz and a lot of shifts and understanding since those early days of hormone research. So where do we stand today? Let's break it down.

[00:16:19] Bree: Research shows that MHT effectively helps with hot flashes, vaginal dryness, night sweats, and bone loss, leading to improved sleep, sexual relations, and overall quality of health. But it's crucial to understand that these benefits come with potential risks, especially when used long term.

[00:16:44] Bree: That's more than three to five years. There appears to be a heightened risk of breast cancer with estrogen progesterone therapy and both types of hormone therapy have been associated with stroke and blood clot risks, especially over [00:17:00] the age of 60.

[00:17:01] Bree: Here's another thing to know. After that big shakeup in 2002, doctors have dialed it down. So now they're prescribing lower doses for shorter periods. Typically that 3 5 year period. Why?

[00:17:16] The Importance of Personalized Medicine

[00:17:16] Bree: Because we've learned that the risks and benefits of MHT are all about timing and personalization. Think about MHT as sort of a double edged sword.

[00:17:28] Bree: It's great for short term relief, but for long term use, especially after the age of 60, the risks for breast cancer, stroke, and blood clots seem to increase. And that's where that personalized medicine comes in. Because every person is unique, and the decision to use MHT should be a team effort between a patient and the healthcare provider, weighing specific symptoms, age, and health history.\ I want to reiterate, for healthy humans, Under the age of 60, [00:18:00] who are within 10 years of menopause, the benefits usually outweigh the risks. And Joanne Manson, professor of epidemiology at Harvard's T.

[00:18:11] Bree: H. Chan School of Public Health says that despite These recent reassuring findings many doctors remain reluctant to prescribe hormone replacement therapy, and a lot of clinicians lack the training to help people assess their personal risk. According to Manson, this means that people who would be appropriate candidates for MHT are actually being denied hormone therapy for the treatment of their symptoms.

[00:18:43] Bree: And we don't want that. The North American Menopause Society, that's NAMS, I've talked about it a lot on this podcast. their latest guidelines from 2022 reinforced this. They confirm MHT's effectiveness, [00:19:00] but they also emphasize the importance of shared decision making and periodic reevaluation of a person's benefit risk profile.

[00:19:09] Bree: It's all about finding the right dose, duration, and method that aligns with the needs of the patient.

[00:19:17] A Note on Bioidentical Hormones

[00:19:17] Bree: Also, I really want to give a quick note about bio identical hormones. There Are concerns. About their safety due to issues like minimal regulation, potential for incorrect dosing, and lack of scientific data about their efficacy.

[00:19:35] Bree: If you want to hear more about bioidentical hormones or compound hormones, check out last week's November 22nd episode that covered those topics.

[00:19:46] Final Thoughts on Menopausal Hormone Therapy

[00:19:46] Bree: So where does this leave us? MHT is not the villain it was once painted to be. But it's also not a magic pill. It's a tool. One that requires careful consideration and [00:20:00] customization.

[00:20:02]

[00:20:02] Bree: Let's quickly recap what we've covered today. We've explored the nuances of MHT, understanding its benefits and acknowledging its risks. It's super important to get an individualized treatment plan and have ongoing conversations with your healthcare professional.

[00:20:19] Community Support and Engagement

[00:20:19] Bree: I encourage you to stay informed and to share your experiences and thoughts with other people. Fostering community support is vital. Remember, you are not alone in this journey. If you're into social media, I suggest that you head over to the pause to go podcast group on Facebook. It's a free group y'all.

[00:20:41] Bree: And in this small, but mighty. Private group of midlife mavens. You can talk about your experiences or ask questions about anything from menopause to midlife career changes. I check that group almost every day and respond to [00:21:00] every person's input.

[00:21:02] Bree: And I would really love to have conversations with you about these important topics.

[00:21:08] Closing Remarks and Preview of Next Episode

[00:21:08] Bree: Thank you so much for joining me today. Stay tuned for our next episode where we will wrap up our series on hormone therapy with tips for choosing and talking to your menopause informed healthcare provider.

[00:21:22] Bree: Thank you for listening to the pause to go podcast. Special thanks to code base co working and WTJU radio for their support. This has been an awkward sage production.