Dr. Barb attended the annual meeting of the North American Menopause Society in Chicago in late September, hearing about ongoing research and developing treatments for women from perimenopause through post-menopause. This year, our colleague and kindred spirit Marta Hill Gray, an advocate for women's health care, was also in attendance, so we planned a conversation between the two of them to share the highlights of the information gathered and their perspectives on the conversation.
Barb: Today, I'm pleased to have with me Marta Hill Grey. I'll let Marta introduce herself, but the reason we're here today is that we both had the recent opportunity to attend the NAMS 2019 meeting, which is the North American Menopause Society. We had an opportunity to be updated on current and anticipated treatments, management, treatment options, some new treatments—emerging options. So Marta and I just wanted to encapsulate our time there and some highlights of the things we experienced. Welcome, Marta.
Marta: Thanks, Barb. Yes, it was a great experience. I have worked in the women's health space now for over ten years, and am a women's health advocate. I work for women of all ages and stages, but of course, I focus on menopause simply because I am a baby boomer and one of us, if you will. I really enjoyed NAMS this year, especially having you translate some of the research for me so that I can understand it as a patient and what it means to me. So I'm excited to talk a little bit about what all of that has meant for you as a physician and for me as a patient who really wants to know more about treatment options and what's coming down the pike for women who are perimenopausal, menopausal, and beyond.
Barb: It wouldn't be possible to really summarize the whole meeting, so I'm just going to talk through a few of the highlights that we did. Some of them we were both in attendance, so you can share some of your insights. But there was a full half-day attributed to the topic of perimenopause, and I think that has become a bit of an area of misunderstanding and lack of recognition. They reviewed that so many physicians just tell women they're too young to be perimenopausal and don't recognize some of the symptoms that may be associated with that, but we took a deep dive into some of the physiology, the actual hormonal changes that occur as a result of being perimenopausal. [We] talked about some of the definitions. I think it's just important to know that perimenopause starts late 30s, early 40s, oftentimes a full decade before menopause. So when women begin to have some symptoms associated with that, they should have a discussion with their provider about that.
There's a lot of new understanding about the nuances of the hormones, and some of the other proteins that are being produced by the ovaries in the body; that it's a very complex system. As Dr. Nanette Santoro, who's a lead voice in women's health and menopause, stated, it's a disruption of many feedback loops, so our brain, our ovaries, our uterus are this very complex system. We talked through irregular bleeding and what the impact of that is, some of the challenges around contraception in being perimenopausal, and reminding women that the ability to conceive or to have a conception is present right until menopause.
And then it was an interesting topic by Dr. Hadine Joffe, who has an interest in hot flashes. Her talk was entitled “The Complex Web of Hot Flashes, Sleep Disruption, Depression, and Wellbeing,” and recognizing that the brain is an endocrine-end organ. I think we're learning more and more all the time about the understanding of hormones and brain, and what the longer term impact might be for those of us in perimenopause and menopause and the implications to those things I just said: sleep disruption, depression, and overall wellbeing.
It's challenging, and many providers—and patients themselves—don't think about the consideration of how hormones may play a role, for instance, in sleep or depression. But we were reminded that there is a direct correlation. Insomnia is over twice as common in perimenopausal women, and major depression is over twice as common in perimenopausal women, too. Then, of course, the all-important metabolic changes that occur during the menopause transition, and how the incidence of type two diabetes become significantly a greater risk, with the mean age of onset at age 52. So it's not surprising that women transition through early menopause, and find themselves with other chronic conditions of which type two diabetes is certainly a major potential outcome.
And then, talking about just an overall healthy menopause transition, Dr. [Cynthia] Stuenkel out of the University of California did an overview of recognizing that cardiovascular disease is the primary killer of women, and it typically manifests—we see onset of those symptoms within a decade or more after menopause. Oftentimes, those risk factors are not recognized or addressed. I think her message was really kind of a call to women to anticipate those chronic disease changes and maybe address lifestyle in advance of being perimenopausal or early menopause. We recognize bone health, again cardiovascular health—a lot of things are impacted, and so if you can take stock in your general health earlier, younger, you're probably going to be more likely in making a successful transition through perimenopause to menopause.
Marta: Don't you think, Barb, that a lot of this then comes down to good communication with your doctor at an early stage; to not dismiss any symptoms, and have a better understanding as you make this transition, as women make this transition?
Barb: I absolutely would agree with that. I think you're right on cue. And I think we anticipate puberty, and we talk to parents about what's to come and what to look for. Parents typically know what sorts of things they need to be on the lookout for. We should be anticipating this with our patients and preparing them, so they can make the proper adjustments. It often does take some significant changes in habits to be most successful, but that doesn't happen overnight, and it's always going to be more successful if it's done in anticipation.
Marta: And I think a lot of women don't think—when they think menopause—risk for heart disease or diabetes or other things that they wouldn't normally correlate with this transition in kind of pre-midlife, midlife. So I think it's really interesting as we try to spread the word to women, "Pay attention. Talk to your practitioner. Make sure they're aware. Nothing is insignificant." A lot of times we as women dismiss that and say, "Well I'm just tired,” or “I don't feel well," and these things can be more serious perhaps than women know or want to acknowledge. So I'm just throwing that out there because that was sort of my takeaway: "Oh my goodness, it's all related."
Barb: Yes. I think the other important message we heard through a number of presenters, just to touch on hormone therapy itself, was the age of initiation matters—this window of opportunity—there's a significant change in the outcome of hormone therapy, both risks and benefits, for women who initiate early. Which hormones you select have a significant impact—the progesterone versus progestin—on safety side-effect profiles is really quite profound. I think we've come a long way in understanding that. And also estrogens; which estrogen do you choose? Is it oral? Is it transdermal? Vaginal for localized? So I think it was a good review of that, and personally, I felt that it was helpful in assuring that I think I'm practicing evidence-based medicine in making those decisions with my patients.
Marta: And can you just touch on quickly what evidence-based medicine is versus not? I don't think a lot of women know the difference or even know it's a thing.
Barb: Evidence-based medicine means we make decisions around treatments or assessments based on really what the clinical trials have taught us is the best way. You need typically double-blind placebo-controlled trials to assure that a treatment either is safe and effective or not. And generally, our decision-making along that—really in any area of medicine, your doctor starts you on a medication—it should be because there is evidence-based medicine to support that decision and treatment, both for safety and efficacy. So I think we didn't talk a lot about it at this meeting, but it was brought up. It always leads back generally in women's health to the compounded treatments. We just don't have those same assurances.
Barb: And while there's some, I think, a fallacy of, “If it's compounded, it must be safe.” It's, I think, the exact opposite. Again, this meeting didn't focus a lot on that, although we did spend a bit of time being updated on that as well.
Another topic I thought was interesting, there was a presentation that was given by Dr. Connie Newman of New York University School of Medicine in New York on heavy drinking among middle-aged women; said subtitle: “A Sobering Issue.” I do think it's an important one that we as clinicians need to be aware of, and as women. It's now called alcoholic use disorder. So we're not talking about alcohol abuse. We're talking about alcoholic use disorder as some of the new terminology. But it's considered one of the most underdiagnosed and undertreated conditions that we have today. She suggested that from the early 2000s, 2001 and 2002 compared to 2012 and 2013, there was an 84-percent increase among women's use of alcohol. Primarily in the age group of 55 to 64 was where that highest increase was seen. Actually, they had the highest increase in frequency of visits to the emergency department for acute alcohol consumption.
And so this was really just a heads-up, I think, for being aware as a woman your alcohol consumption and why you are drinking. She shared reasons for frequent drinking tends to be the beliefs that alcohol "causes relaxation," "it's the remedy for a stressful week." I'm sure most of us can relate to that, but I think just that bit of caution around the slippery slope of use and overuse and there are some health impacts….
Marta: Do you see that in your patients? Do you see that?
Barb: You know, I do see that. One of the questions we ask about is, "Have you tried to stop? Have you tried to drink less?" That usually indicates awareness that what I am doing maybe is verging on more than I should, and I think many women will admit to that. So they recommend a screening. She shared a validated screening tool. It's a ten-question audit test. And there's also another four-question CAGE survey to help identify those who may be somewhat abusing or overusing. [Ed. note: CAGE comes from key words in the assessment: Cut down, Annoyed at criticism, Guilty about drinking, Eye-opener drink.]
So again, I think it's just one of those areas of concern. And women are just a little bit more likely to experience adverse health consequences related to alcohol because we're smaller, we have a lower body water, we have higher body fat, and it takes relatively lower amounts of alcohol to have some negative impact compared to men. So this was a reminder in the meeting where we talked about the risk of breast cancer. There's a 12 percent increase in breast cancer for every one serving of alcohol per day. So for women who think it's okay to do two to four servings, you may be increasing your risk of breast cancer upwards of 40 to 50 percent over average if you are consuming that much alcohol per day. So for multiple reasons, we want women to be somewhat more aware and sensitive to the alcohol risk.
Do you observe that, Marta, in your circles? Do you relate to this and see this as potentially an area of concern?
Marta: I do. I wonder if it's the sugar in alcohol, too, that can be a problem, but I find that friends of mine when they complain about their weight say, "Well I guess I have to stop drinking." And I'm not a drinker, so I observe it though with my friends, and I find especially wine is a big deal in women in our age group. They do tend to find it relaxing. It's social. It tastes good to them. They like the little bit of a buzz they might get. So I do think that it is frequent and popular, but I also see how it can be a slippery slope for a lot of women. And the breast cancer information related to that is tremendously important, I think.
Barb: Yes. Yeah. Then we had another lecture entitled “Postmenopausal Patients Want to Talk About Sex and Aging.” So of course this is an area that's somewhat near and dear to my heart.
Barb: Dr. Holly Thomas from the University of Pittsburgh spent some time talking about—and these are some of her statements—older female patients with low libido are looking for more information about what's normal in regard to sexuality and aging, and they want to talk about it with their providers. So women need high-quality, accurate information about what's normal, and more opportunities to dialogue about these issues with both their healthcare provider and their peers was some of the statements she made around the presentation. So not only just their provider but even they want to talk amongst trusted friends. She did numerous focus groups and she, again, highlighted some areas I think we already knew were important, and that is sex is important to women, and they want to push back against society that tells them to suppress their sexuality. Anything that says that they shouldn't be sexual women over 60, they want to give a different statement. I think you've been sort of in the trenches around some of these discussions, Marta. Can you comment on that?
Marta: Yup. Well, Barb, you and I have actually discussed this over time, and yes, I think women are really wanting more information and to have the conversation. My concern is that in medical school I wonder is menopause discussed? And certainly sex for women of a certain age who are menopausal, is that even a thing? And so I think women have some concerns around who to talk to about this. They tend to talk to each other, and ask what's going on with your body, and are you sexually active, and how do you get there because things have changed. It's not the same as when you were 25. So I think it's a big deal, and I'm really hoping that the providers heard this and they will open up the dialogue for women, because I think it's a hard one for a lot of women to discuss, especially of a certain age and generation where it wasn't as open and easy as it appears to be for young people today. So I think there are a lot of taboos around it still, and I'm guessing you see that in your practice, too, that you have to really bring it up and make it okay.
Barb: I think we've come a long way, but obviously we still have a ways to go in the fact that this was presented as one of the lectures at a large meeting like this. So yeah, we keep marching forward.
One other thing I wanted to take just a couple minutes on was there was a study called the Vital, V-I-T-A-L Study and it assessed Vitamin D, 2000 IUs a day and omega-3 fatty acids, one gram a day, and just some pointers about what did this large trial—and this is going to be ongoing; there'll be more data coming from this—but just to say specifically to the omega-3 fatty acid, again, one gram a day, the cardiovascular outcomes were there was a small, but not significant, reduction in major cardiovascular events. That included a 28-percent reduction in MIs. So that piece itself was probably the highlight that omega-3 fatty acid had a 28-percent reduction in MI occurrence. There was no change in strokes. Overall cardiovascular mortality, there was no change. The fatal MI was reduced somewhat. So it was felt to overall show probably some benefit around cardiovascular disease, and this included both men and women. There was no reduction in cancer with omega-3 fatty acids.
They also looked at Vitamin D and recognize that Vitamin D is associated with a lot of chronic diseases. The question is, is it critical to supplement? In their outcomes, they saw there was no significant cancer change for women who did vitamin D. I would say, in our specific breast cancer data, we do suggest that a low Vitamin D does have some associated increased risk with breast cancer. In these trials, cancer types were not broken out; it was just an overall cancer diagnosis. The cancer death rate that occurred with Vitamin D supplement was somewhat lessened. A hazard ratio of 0.75, meaning you had a 25-percent improvement (or reduction) in the likelihood of a cancer death. And that was the data that after two years from initiating the Vitamin D, they looked at the cancer test. So assuming maybe upon initially supplementing it, it might not have had protection, but maybe farther out. So there might be some suggestion of benefit there.
They also found no benefit for depression with omega-3 fatty acids. No benefit with cognition from the omega-3 fatty acids. Vitamin D, no benefit with depression. Again, I would say I have patients who have seasonal affective disorder who feel like there's some improvement around their depression upon using it, especially in the winter months, but this clinical trial didn't suggest there were significant changes. And also with cognition, they felt that Vitamin D didn't help in any significant way. So back to trying to make the right decision for the right reason, fortunately they didn't see any negative impacts, no side effects, no adverse events with supplementing these to commonly use supplements. So no harm, maybe some benefit, especially around MIs with omega-3 fatty acid, and cancer with Vitamin D.
I thought there was one other interesting medication that we're starting to hear about emerging. Marta, I think you were in a meeting with me. We had a conversation about a brand new treatment option around treating hot flashes, non-hormonal. This is what's called neurokinin 3 receptor modulator. So it is known that, in the brain, we have a thermoregulatory control area that is impacted by menopause, and is the trigger of hot flashes. There is a new medication entering phase-three clinical trials looking at the neurokinin 3 receptor neurons and impacting that. It's a NK3R antagonist, meaning it blocks that activity, and it showed some significant reduction in the frequency and severity of moderate to severe hot flashes. Looks like it was well tolerated. So again, further trials are underway. So we're eager to think about additional options to offer patients for bothersome menopausal treatment management.
Marta: Yeah. It's wonderful, isn't it? I think there are a lot of treatments that are coming through clinical trials now. That one especially is exciting, especially for women who that's their only option; that they're not going to be able to take hormones, so that this is a way to get that relief from those pesky hot flashes. So great.
Barb: Yeah, it's been my experience that that's the number one complaint for women in menopause, and oftentimes it's the night sweats because it disrupts their sleep. Statistics say 80% of women during menopause are going to have those, and for a variety of reasons, women don't want to choose a hormone option. We just don't have good data on so many of the supplements that are out there being offered. So again, we're back to placebo-controlled double-blinded clinical trials to give us evidence-based FDA-approved products. Hopefully, someday FDA-approved. Obviously, that process will be ahead of them, but it's exciting to know that there's really a lot of interest and effort and research being put into this area. So I think women can be encouraged by that aspect.
Marta: Would you say these products are looking to be out, roll out in the next three to five years? Or sooner?
Barb: That's their goal that they would be to market. Yeah, I would hope sooner, but I think the processes that have to be in place before approval are... It's a heroic effort on the part of these pharmaceutical companies, but I think three to five is a reasonable expectation. So we'll be eagerly awaiting that.
Let's talk a little bit about the exhibit hall. There was one product in particular that I was interested in and you happen to know a little bit, probably even more about this product. It's called vFit.
Marta: Yes, it was started or created by a woman who had been in the skincare industry. So she had been doing the aesthetics and facials and that kind of thing for the skin on the face and the neck. She pursued further what are the other options to do things to help women vaginally, and to get in there to help some of the symptoms that come with being female, getting older, many other things. She got all the smart people she could to help her with this product. She has really, really done well. Colette [Courtion, founder and CEO] is just a really bright light out there in the women's space. The company is called Joylux, but the product, Barb, maybe you can articulate it from your point of view in terms of what it does. But I think it was interesting that it was started by a woman who was treating the external skin and then took it to another level based on what she knew and the impact.
Barb: Yes. So the actual term used for this technology is called photobiomodulation. Again, I think we've seen in a number of cases what's been created for cosmetic and skin reasons has been translated to more disease states I will say. For instance, Botox. Botox is being used in treatment for urinary incontinence. It's being used for migraine headaches. So some of this photo-treatment is now being applied to the vagina. As we know, this condition called genitourinary syndrome of menopause has a significant impact to the genitals, the vulva, vagina, a negative impact for women experiencing menopause. The consequences of that are usually related to painful intercourse, just some day-to-day discomfort, irritation, and maybe bladder function, maybe more urgency or frequency.
So they've used this photobiomodulation clinically now to apply that light source to the vagina. It uses red and near-infrared radiation light. It's applied to those tissues to promote healing, so to speak, of skin, improving the integrity of those tissues and returning some of the moisture. So this device—now we've had lasers in people's office, lasers and radio frequency—those devices cost a clinician around anywhere $150,000. Patients are paying usually around $1,200 for a course of treatment that then, for a lesser cost, needs to be updated annually. But this is taking that and putting it in a handheld device that women can own, and have, and use on their own. And they're pricing it around $500.
So in theory, when you think about prescriptions and copays that it might replace or these other needing to go in for an office visit or a series of office visits, to take this technology so women could do this at home on their own, continue the maintenance therapy to continue the success, I think is really exciting, and I'm eager to learn more about it. I got the information about it. It’s bright people in this space who are trying to improve the quality of women's health and taking their passion and bringing it to us.
Marta: Exactly. Wonderful. Would this be in place of treatment or would you... I mean I know it's still new to you on some level, but how would this replace or complement other treatments?
Barb: My understanding is this could replace it. On the other hand, I think for those who maybe have had either prescription therapies or laser therapies already in place, it maybe would be something they could use to continue to maintain. Because this is a condition that requires ongoing therapy. You don't treat it once and then ride off into the sunset and have it be effective ongoing. The condition relapses unless it's under continuous and ongoing therapy. So I think this would be a standalone therapy option for women. So it's called vFit.
Marta: Great. Will you be offering it on your website at some point?
Barb: I would love to maybe carry it through my website. We'll have to work with the company and see if that would be an option for them to allow MiddlesexMD to help them promote it and make it available. It looks safe and effective, and hopefully we could make it cost effective for individuals as well.
Barb: Good. Are there any other highlights from the meeting we didn't touch on, Marta?
Marta: No, I think that's a pretty good summary. There were some other things that came up, but we could be here all day talking about it. I think that it's exciting and interesting to see so many engaged doctors and nurse practitioners and companies, pharmaceutical and non, who are looking to really have the conversation with women about menopause, increase their options, make it less traumatic, and ease the symptoms so that women can live their best lives well into their later years.
Marta: So thank you to you for being one of them, and it's really... I think it's just going to be so much better for the next generations. Think about what our mothers and our grandmothers went through. My goodness. It was “the change,” and nobody talked about it.
Barb: Yeah, you are absolutely right. Well, thanks for sharing your time with me at the meeting, and thanks for sharing your time with me this morning.
Marta: Thanks, Barb.