Welcome to our guide for surviving surgical menopause. Congratulations for setting out to learn more about your body and needs in this challenging time!
Because this site uses blogging software, this home page can be a little confusing and, frankly, isn't the best of places to begin reading. Instead, we suggest you begin by reading the "Introduction" tab above, and then move along to the "Table of Contents" page. Working from that to read one article after another in that order will make a great deal more sense for you. And don't forget, if you're looking for something specific, that there's a search field in the left side of the upper pink navbar. Still can't find what you need? Come join us on our forums and we'll try to help you out.
Oxybutynin: a new addition to drugs effective for hot flash suppression
Research announced at the 2018 San Antonio Breast Cancer Symposium has demonstrated that oxybutynin is more effective in suppressing hot flashes than the current drugs of choice, venlafaxine or citalopram.
As this is posted, drug coupon source GoodRx lists a retail cost of $42.09 for 60 5 mg tablets, but offers coupons to bring that cost down $20-25. Insurance coverage will depend upon individual companies' policies and agreements with pharmacies and manufacturers.
In addition to women with hormone-receptor-positive cancers, especially those taking tamoxifen which contraindicates the use of many SSRIs, this product may be helpful for other women, such as endo sufferers, who are looking for non-hormonal control of their symptoms.
"We have to be cautious, as these are cross-trial comparisons, but oxybutynin shows a more significant decrease in hot flash score [than anything else so far], so with the results of this particular study, we will be more keen on using oxybutynin now," he said. (source)In more detail, researchers tested both doses of oxybutynin, 2.5 mg and 5 mg, and found:
measures related to sleep, leisure activities, work, and relationships, were significantly better in comparison with women who received placebo.But as we all know, there is no such thing as a free lunch.
However, neither dosage of oxybutynin offset the effect that hot flushes had on patients' ability to concentrate or on their sexuality. At the lower dosage, oxybutynin did not improve mood or enjoyment of life; at the higher dosage, improvements were seen for these measures. (source)
Side effects were as expected with any anticholinergic and included dry mouth, abdominal pain, and difficulty urinating with both dosages.Here are the FDA product information files for the 5 mg dose strength. The product is also available in extended release and syrup forms with a total FDA listing here.
At the higher dosage, oxybutynin also increased the risk of developing dry eyes, as well as risk for episodes of confusion, diarrhea, and headaches. (source)
As this is posted, drug coupon source GoodRx lists a retail cost of $42.09 for 60 5 mg tablets, but offers coupons to bring that cost down $20-25. Insurance coverage will depend upon individual companies' policies and agreements with pharmacies and manufacturers.
In addition to women with hormone-receptor-positive cancers, especially those taking tamoxifen which contraindicates the use of many SSRIs, this product may be helpful for other women, such as endo sufferers, who are looking for non-hormonal control of their symptoms.
Bijuva: a new combination HRT
Approval of a "new" hrt made some press headlines for Bijuva. There is not yet a label available (update: see below) from the FDA, but the Reuters press release describes it as
an oral softgel capsule containing a combination of artificial hormones chemically identical to human female sex hormones estradiol and progesterone.
Other press sources are calling it things like "the first and only FDA-approved bio-identical* hormone therapy," which is perhaps stretching things just a bit by implication. It seems to be simply human-identical estradiol and human-identical progesterone in one pill, with the dose it contains identified in releases as 1 mg/100 mg. The "artificial hormones" aspect is simply an overly precise way of stating that they are produced in the laboratory, as is the case with all human-identical hrts, instead of being refined from animal sources, as Premarin is, to produce synthetic or non-human-identical hormonal agents.
So that means that this new pill (which could be expensive because it's new) contains the same things as a generic Estrace 1 mg, one of the cheapest hrts around, plus a 100 mg capsule of Prometrium, also an older formulation. The "new" about this is simply the combination, not actually the fact that FDA-approved human-identical hrts are available in oral dose form.
It's also worth noting that the name, Bijuva, is quite similar in sound to the now-discontinued hrt, Enjuvia. Bijuva is not a replacement for Enjuvia: it contains entirely different hormonal formulations.
So is this a real improvement? If this is the precise dose that any given woman needs and if she finds that the convenience of taking one pill rather than two is worth paying for, then yes, it might be. If her insurance company cuts a deal with the manufacturer or supplier such that they can beat the price of that same supplier for the two separate hrts, she may not have a choice. But for a woman who is in the early stages of working out her needs or who hopes to customize her dose, it could be less suitable because she is locked into just those two doses.
Unlike progesterone-only gelcaps which can be used vaginally, this hrt would not be suitable for vaginal use because of the high dose of estrogen it contains (read more about why taking systemic doses of the active estrogen via pelvic circulation delivery is not necessarily the best idea ever).
And, like all oral hrts, it would provide delivery-related effects that may not be the best option for some women.
The press releases suggest that this new formulation will come on the market in late 2019. We'll keep an eye out and update this and our combination hrts listing page once the FDA releases the full packaging information for it.
Update: Here's the full FDA product sheet for Bijuva.
Hot weather and your HRT
While questions about HRTS and hot temperatures have come up before, increasingly disastrous summer weather all around the world has really made this topic gain more urgent attention.
There are two aspects to this issue: transporting/storing hrts and using them, and both are affected by heat and humidity.
All hrts are affected by temperature and humidity to some degree.
That is the notional reason why hrts have expiration dates (although that period may also be affected by marketing and sales). Further, pharmaceutical manufacturers only guarantee their products' effectiveness within the range of 68-77F (20-25C) although pharmacists tend to support the broader range of 58-86F (14.4-30C) as non-damaging.
Estrogen itself may lose potency when heated, although it's difficult to find specific references that detail this process and much of it is cloaked in spurious dietary advice. Nonetheless, it's a complex molecule and it only works when undamaged.
Irrespective of whatever happens to the estrogen molecule itself with heat, though, other aspects of specific hrt deliveries can definitely be adversely affected by heat.
Oral tablets, whether meant to be swallowed or used transbuccally, will lose more potency over time at high temperatures than cool ones. High humidity getting into pill bottles may also cause tablets to crumble or capsules to stick together and break when attempts are made to separate them. This can affect dose strength and thus how our needs are covered by our usual dose.
Creams may melt and separate in the heat. Sure, you can stir them back together, but that's still iffy in terms of the exact distribution of the active ingredient through the vehicle. Gels may be less well--absorbed if their alcohol-based vehicle evaporates so quickly in the heat that we can't spread them to the required area size, and they may become more concentrated as alcohol evaporates out of the container. Sprays and lotions are liable to suffer similar effects that can change potency of a dose, whether by affecting dilution or application.
Over the years, we've heard of a number issues to do with patches and heat. A common one is the effect heat can have on the adhesive, which is necessary for the delivery of the estrogen the patch contains. Patch brands that previous adhered fine may no longer stick for the full dose period or may no longer adhere fully.
Let's segue from patch adhesion concerns due to adhesive damage into the other issue to do with using hrts in the heat: our bodies. There are two things going on here.
First, there's sweat. Even an otherwise fully adhesive patch may falter when placed on sweaty skin. Similarly, sweat may dilute other transdermals like creams, gels, or sprays, changing the spread area and uptake speed.
Beyond that, though, heavy sweat after application can cause a patch to lift. It can also wash away (or transfer to others) estrogens cached on top of the skin, such as those applied by gel or spray. Only oil-based creams penetrate the skin fully at time of application and are not affected by later sweating. Now, this obviously may not apply to a light "glow" but when we spend an hour or a day or days and nights pouring sweat, then we're dealing with a substantial possibility.
But not all damage to hrts comes while we're applying them. They also have to get into our hands in the first place and then from there into/onto our bodies.
HRTs are shipped from the plant where they are manufactured, stored in a warehouse, redistributed/retransported once or several times by a pharmaceutical chain, and stored in the pharmacy all before they come to us, after which we may carry them around or leave them in our car parked while we carry out other errands. Additionally, if we use a mail-order pharmacy plan, the prescription mailer is stored and handled by a shipping service, spends a day or more being driven around in an open delivery truck, and then spends time in our mailbox, which itself may be outdoors or in a temperature-uncontrolled space. Can you see all of the times and places where your prescription could bake in the heat (or freeze in the cold for winter refills)? Because most hrts don't require refrigeration, they may not be handled in ways that preserve that relatively narrow range of effective temperature. And there's no way for us as customers to know that these things may have happened.
And of course, once we do get them home, many of us are finding that where historically we didn't need air conditioning to get through summer weather, we're now living in much hotter temperatures. Our homes may spend days or even weeks at the elevated levels that damage hrts.
So what can we do? We have no control over what happens before we're holding our hrts in our hands, and the many commercial interests that control them upstream of us have, at the moment, little incentive or regulatory interest in minimizing damage. Similarly, we've not heard much about insurance refusing to cover replacements of heat-damaged hrts. But as this problem grows, we might expect them to move to protect their profits by making new policies to limit refill coverage. This comes down to fiscal politics, which is rather outside the purview of this website but certainly a concern for many of us in the world we live in.
But once we've got control over our hrt, we can take steps to preserve what potency it might have.
If you're using a mail-order service, is that negotiable with your insurance? Can you document heat damage (photos are your friend, here) to packaging or mailboxes in the hot sun? Can you arrange quicker pickup of the mail or move the mailbox to a shaded location? Sometimes once we figure out where problems can occur, we can take steps to reduce their likelihood.
If you're picking your prescription up from the pharmacy, you may be able to avoid leaving it in a hot locked car while you finish your shopping. Basically, if you wouldn't leave your child or your pet in that locked car, it's also too hot to leave your hrt.
What about at home? To begin with, the bathroom is the worst place in the house to keep your hrt because of all rooms, its the most likely to become even hotter and even more humid as you use it. So yeah, it may be convenient...right up until your hrt doesn't function well enough any more.
Going in the other direction, refrigerators are cooler than the recommended temperatures, so they aren't the best choice either. Still, if we were trying to decide between a 100F+ room and a refrigerator, we'd seal our hrt up well (to prevent moisture damage) and put it in the fridge. If you have a basement, that may be slightly cooler if you have access to a secure location in it. You may need to search to find the coolest place in your home and even then it might not be cool enough. But it's still good to get those hrts out of the bathroom.
Obviously, if you have air conditioning that's going to help a lot. But many of us don't have the money or even the time to put this in place, especially if we don't own where we live. In a pinch, there are a number of clever cooler concepts that have been developed for third world countries that can be adopted to create small, custom coolers or to cool the air without electrical appliances (1, 2, 3).
It seems obvious that we should do what we can to keep our use of hrts as unaffected by the heat as possible. But when our bathroom is roughly the temperature of the surface of the sun, it may be difficult to actually dry our skin off enough to apply an hrt. Additionally, because our pores are open and blood vessels close to the skin are dilated to the max to try to dump excess body heat, our bodies may take up our hrts much faster than in cooler weather. Both of these things may affect how we feel on our hrts.
What to do? Once we're aware of the issue, we need to do some personal troubleshooting. Is there a (slightly) cooler part of the house we could go to and cool down a bit before applying our hrt? Can we stand in front of a fan until our temperature normalizes a bit? Should we even go so far as to switch the time of day of taking our hrt, even knowing that this might put us in conflict with our natural biorhythm of higher estrogen levels in the morning? Do we need to take special precautions around kids or pets to avoid sweating some of our hrt onto them? All of these will require personal answers and troubleshooting, but they're things to consider. The inconvenience of changing our routines for hot weather (and then remembering to actually do them!) may well be offset by not having to endure hormonal instability. Overheating is annoying enough without adding hot flashes and mood instability from fluctuating estrogen.
Beyond keeping things cool, sealing pills or sprays in a plastic bag might help protect them, a bit, from either humidity (pills) or excess evaporation (spray canister).
Well, some signs are obvious. If you open your mailbox and find a stained parcel or the hrt packaging itself shows signs of leakage, taking a photo and then taking steps to return that hrt is a good place to start.
But mostly, it's not going to be obvious. It's more likely to show up in how our hrt works for us. If we've been stable on this hrt at this dose for a time and suddenly things are falling apart, it's not that our hrt has "stopped working" or some other magical effect has taken place ("jammed receptors" or "needing a hormone holiday" are some of the popular but incorrect mythologies). It may be that our hrt just isn't delivering that dose due to heat damage or heat effects upon delivery. But this is a tricky call, one that takes some thought. Extreme hot weather is a stressor in itself, and we know that stresses, especially ones that linger on for a week, two weeks, or more can also upset our hrt balance. But as we troubleshoot loss of balance in hot weather, we shouldn't forget the heat/hrt damage as one possible cause.
So should we just double up on our hrt in the heat? No, that's likely to be a too-sweeping change. Really, a better first option would be to try to get a replacement refill that hasn't been damaged and to store it as appropriately as we can manage. But if we're stuck with a damaged batch and need to make the best of it we can, it's probably going to be less stressful and more on-target to slowly increase the amount we're using by no more than 10% of a usual dose at a time. That lets us feel our way to "right" rather than risking the even worse discomforts of an excessive dose. And, of course, it's important not to forget to revert to the correct dose again with the next refill. Even if it's still hot? Yes, because we won't know precisely how damaged this one is, and the adjustment for one batch may not at all be the adjustment needed for the next.
This also applies to our summer vacations. We may have fine temperature control at home, but how about when we've packed the whole family in the car and headed off to [vacation destination] with our hrt stashed in a suitcase in the trunk? Taking care to keep our hrt within temperature range during travel and at our destination is a annoyance, but also can go a long way towards reducing the risk of losing our hormone balance while we'd rather be having a nice time on vacation.
And one last word on wildfires and other climate disasters. With increasingly extreme heat comes dryness and risk of fires, often in heavily-inhabited areas, or more violent hurricanes affecting areas further inland. The wise thing to do as our climate changes is to have an evacuation plan, if not "go bag" with essentials (this is a basic example of what to include, but an online search will reveal many more articles and lists). While we may not keep our prescriptions in them, having a grab-at-the-last-minute checklist so that we're reminded to take them with us can be essential to our health. Losing a home or being relocated is traumatic enough; in an evacuation scenario, it can be extremely difficult to get needed prescription refills and in some cases, insurance companies may not deem that an adequate justification for them. There are many resources online about how to put together evacuation bags, but for those of us on hrt, that's a critical piece to include.
No matter where you are in your annual climate cycle, we can look forward to heat, extreme weather, and wildfires becoming the new norm as our planetary atmosphere grows ever warmer and more violent. We all need to be aware of the special vulnerability our HRTs represent and take steps to plan to protect them as much as we can.
There are two aspects to this issue: transporting/storing hrts and using them, and both are affected by heat and humidity.
HRTs and heat
All hrts are affected by temperature and humidity to some degree.
That is the notional reason why hrts have expiration dates (although that period may also be affected by marketing and sales). Further, pharmaceutical manufacturers only guarantee their products' effectiveness within the range of 68-77F (20-25C) although pharmacists tend to support the broader range of 58-86F (14.4-30C) as non-damaging.
Estrogen itself may lose potency when heated, although it's difficult to find specific references that detail this process and much of it is cloaked in spurious dietary advice. Nonetheless, it's a complex molecule and it only works when undamaged.
Irrespective of whatever happens to the estrogen molecule itself with heat, though, other aspects of specific hrt deliveries can definitely be adversely affected by heat.
Oral tablets, whether meant to be swallowed or used transbuccally, will lose more potency over time at high temperatures than cool ones. High humidity getting into pill bottles may also cause tablets to crumble or capsules to stick together and break when attempts are made to separate them. This can affect dose strength and thus how our needs are covered by our usual dose.
Creams may melt and separate in the heat. Sure, you can stir them back together, but that's still iffy in terms of the exact distribution of the active ingredient through the vehicle. Gels may be less well--absorbed if their alcohol-based vehicle evaporates so quickly in the heat that we can't spread them to the required area size, and they may become more concentrated as alcohol evaporates out of the container. Sprays and lotions are liable to suffer similar effects that can change potency of a dose, whether by affecting dilution or application.
Over the years, we've heard of a number issues to do with patches and heat. A common one is the effect heat can have on the adhesive, which is necessary for the delivery of the estrogen the patch contains. Patch brands that previous adhered fine may no longer stick for the full dose period or may no longer adhere fully.
Where HRTs run into heat (and cold) problems
Let's segue from patch adhesion concerns due to adhesive damage into the other issue to do with using hrts in the heat: our bodies. There are two things going on here.
First, there's sweat. Even an otherwise fully adhesive patch may falter when placed on sweaty skin. Similarly, sweat may dilute other transdermals like creams, gels, or sprays, changing the spread area and uptake speed.
Beyond that, though, heavy sweat after application can cause a patch to lift. It can also wash away (or transfer to others) estrogens cached on top of the skin, such as those applied by gel or spray. Only oil-based creams penetrate the skin fully at time of application and are not affected by later sweating. Now, this obviously may not apply to a light "glow" but when we spend an hour or a day or days and nights pouring sweat, then we're dealing with a substantial possibility.
HRTs in transit and storage
But not all damage to hrts comes while we're applying them. They also have to get into our hands in the first place and then from there into/onto our bodies.
HRTs are shipped from the plant where they are manufactured, stored in a warehouse, redistributed/retransported once or several times by a pharmaceutical chain, and stored in the pharmacy all before they come to us, after which we may carry them around or leave them in our car parked while we carry out other errands. Additionally, if we use a mail-order pharmacy plan, the prescription mailer is stored and handled by a shipping service, spends a day or more being driven around in an open delivery truck, and then spends time in our mailbox, which itself may be outdoors or in a temperature-uncontrolled space. Can you see all of the times and places where your prescription could bake in the heat (or freeze in the cold for winter refills)? Because most hrts don't require refrigeration, they may not be handled in ways that preserve that relatively narrow range of effective temperature. And there's no way for us as customers to know that these things may have happened.
And of course, once we do get them home, many of us are finding that where historically we didn't need air conditioning to get through summer weather, we're now living in much hotter temperatures. Our homes may spend days or even weeks at the elevated levels that damage hrts.
So what can we do? We have no control over what happens before we're holding our hrts in our hands, and the many commercial interests that control them upstream of us have, at the moment, little incentive or regulatory interest in minimizing damage. Similarly, we've not heard much about insurance refusing to cover replacements of heat-damaged hrts. But as this problem grows, we might expect them to move to protect their profits by making new policies to limit refill coverage. This comes down to fiscal politics, which is rather outside the purview of this website but certainly a concern for many of us in the world we live in.
But once we've got control over our hrt, we can take steps to preserve what potency it might have.
If you're using a mail-order service, is that negotiable with your insurance? Can you document heat damage (photos are your friend, here) to packaging or mailboxes in the hot sun? Can you arrange quicker pickup of the mail or move the mailbox to a shaded location? Sometimes once we figure out where problems can occur, we can take steps to reduce their likelihood.
If you're picking your prescription up from the pharmacy, you may be able to avoid leaving it in a hot locked car while you finish your shopping. Basically, if you wouldn't leave your child or your pet in that locked car, it's also too hot to leave your hrt.
What about at home? To begin with, the bathroom is the worst place in the house to keep your hrt because of all rooms, its the most likely to become even hotter and even more humid as you use it. So yeah, it may be convenient...right up until your hrt doesn't function well enough any more.
Going in the other direction, refrigerators are cooler than the recommended temperatures, so they aren't the best choice either. Still, if we were trying to decide between a 100F+ room and a refrigerator, we'd seal our hrt up well (to prevent moisture damage) and put it in the fridge. If you have a basement, that may be slightly cooler if you have access to a secure location in it. You may need to search to find the coolest place in your home and even then it might not be cool enough. But it's still good to get those hrts out of the bathroom.
Obviously, if you have air conditioning that's going to help a lot. But many of us don't have the money or even the time to put this in place, especially if we don't own where we live. In a pinch, there are a number of clever cooler concepts that have been developed for third world countries that can be adopted to create small, custom coolers or to cool the air without electrical appliances (1, 2, 3).
HRTs in use in the heat
It seems obvious that we should do what we can to keep our use of hrts as unaffected by the heat as possible. But when our bathroom is roughly the temperature of the surface of the sun, it may be difficult to actually dry our skin off enough to apply an hrt. Additionally, because our pores are open and blood vessels close to the skin are dilated to the max to try to dump excess body heat, our bodies may take up our hrts much faster than in cooler weather. Both of these things may affect how we feel on our hrts.
What to do? Once we're aware of the issue, we need to do some personal troubleshooting. Is there a (slightly) cooler part of the house we could go to and cool down a bit before applying our hrt? Can we stand in front of a fan until our temperature normalizes a bit? Should we even go so far as to switch the time of day of taking our hrt, even knowing that this might put us in conflict with our natural biorhythm of higher estrogen levels in the morning? Do we need to take special precautions around kids or pets to avoid sweating some of our hrt onto them? All of these will require personal answers and troubleshooting, but they're things to consider. The inconvenience of changing our routines for hot weather (and then remembering to actually do them!) may well be offset by not having to endure hormonal instability. Overheating is annoying enough without adding hot flashes and mood instability from fluctuating estrogen.
Beyond keeping things cool, sealing pills or sprays in a plastic bag might help protect them, a bit, from either humidity (pills) or excess evaporation (spray canister).
How will you know if your HRTs are heat-damaged?
Well, some signs are obvious. If you open your mailbox and find a stained parcel or the hrt packaging itself shows signs of leakage, taking a photo and then taking steps to return that hrt is a good place to start.
But mostly, it's not going to be obvious. It's more likely to show up in how our hrt works for us. If we've been stable on this hrt at this dose for a time and suddenly things are falling apart, it's not that our hrt has "stopped working" or some other magical effect has taken place ("jammed receptors" or "needing a hormone holiday" are some of the popular but incorrect mythologies). It may be that our hrt just isn't delivering that dose due to heat damage or heat effects upon delivery. But this is a tricky call, one that takes some thought. Extreme hot weather is a stressor in itself, and we know that stresses, especially ones that linger on for a week, two weeks, or more can also upset our hrt balance. But as we troubleshoot loss of balance in hot weather, we shouldn't forget the heat/hrt damage as one possible cause.
So should we just double up on our hrt in the heat? No, that's likely to be a too-sweeping change. Really, a better first option would be to try to get a replacement refill that hasn't been damaged and to store it as appropriately as we can manage. But if we're stuck with a damaged batch and need to make the best of it we can, it's probably going to be less stressful and more on-target to slowly increase the amount we're using by no more than 10% of a usual dose at a time. That lets us feel our way to "right" rather than risking the even worse discomforts of an excessive dose. And, of course, it's important not to forget to revert to the correct dose again with the next refill. Even if it's still hot? Yes, because we won't know precisely how damaged this one is, and the adjustment for one batch may not at all be the adjustment needed for the next.
Special cases
This also applies to our summer vacations. We may have fine temperature control at home, but how about when we've packed the whole family in the car and headed off to [vacation destination] with our hrt stashed in a suitcase in the trunk? Taking care to keep our hrt within temperature range during travel and at our destination is a annoyance, but also can go a long way towards reducing the risk of losing our hormone balance while we'd rather be having a nice time on vacation.
And one last word on wildfires and other climate disasters. With increasingly extreme heat comes dryness and risk of fires, often in heavily-inhabited areas, or more violent hurricanes affecting areas further inland. The wise thing to do as our climate changes is to have an evacuation plan, if not "go bag" with essentials (this is a basic example of what to include, but an online search will reveal many more articles and lists). While we may not keep our prescriptions in them, having a grab-at-the-last-minute checklist so that we're reminded to take them with us can be essential to our health. Losing a home or being relocated is traumatic enough; in an evacuation scenario, it can be extremely difficult to get needed prescription refills and in some cases, insurance companies may not deem that an adequate justification for them. There are many resources online about how to put together evacuation bags, but for those of us on hrt, that's a critical piece to include.
Plan ahead
No matter where you are in your annual climate cycle, we can look forward to heat, extreme weather, and wildfires becoming the new norm as our planetary atmosphere grows ever warmer and more violent. We all need to be aware of the special vulnerability our HRTs represent and take steps to plan to protect them as much as we can.
The redemption of HRT
Ding dong! The witch is dead! Or, at least, the witch-hunt over hrts.
The beginning lay, catastrophically, with the cancellation of the Women's Health Initiative Study in 2002. There was a huge worldwide panic in the press, with the end message that using HRTs caused breast cancer. An immediate response followed, in which roughly 50% of the women in the US stopped taking HRT. Over time, attempts were made to suggest other ways of interpreting the data and stances softened, but the basic message persisted: HRT was too dangerous to use.
Whilst HRT supporters continued to explore how hormonal support in menopause, especially surgical menopause, could still be safely used, the costs began to accrue. Studies have suggested that nearly 50,000 women in the US, who were in surgical menopause and quit HRTs because of the study-related panic, died due to that decision.
Further, there were significant fiscal costs both to women and to the general economy from the morbidity due to hot flashes and other untreated menopausal issues. Between 1999 and 2011, says one study:
But misery isn't measured in currency or even deaths alone. The vast number of women untreated and told to swallow their symptoms because they were "just depressed" or otherwise had failed at talking themselves out of anything more than "a few warm spells" (the classic medical description of menopause presented by many doctors) cannot be counted. But we felt it and we saw it in the discussions online amongst the menopause community, as women struggled to make sense of their symptoms in a climate that forbade them treatment and turned the blame back on themselves. At best, we hoped that with time the more sensible interpretations of the study outcome would take hold and those stances would soften in the decades ahead.
And that's how things continued until March of 2017. That's when a startling review article was published in Climacteric, the journal of the International Menopause Society, by R.D. Langer, whose background is cited as:
R. D. Langer (2017): The evidence base for HRT: what can we believe?,
Climacteric, DOI: 10.1080/13697137.2017.1280251 (alternate link)
Basically, the author asserts that many of the research team were shut out of the decision to publish the initial WHI results (which resulted in the study cancellation) paper and were given neither time to review the release nor comment upon it. Further, the timing worked out such that the press release came out before anyone capable of reading the results could have access to them. And, finally, the press release itself was manipulated to emphasize the breast cancer risks...even though they did not exist when the data was correctly analyzed. The author summarizes in terminology rare in the medical press:
Where could we expect to go from there? At the time, in presenting it to our discussion group, we suggested:
Well, as it turns out, we were wrong and we couldn't be happier about that.
Although they released the news on a major US holiday weekend, the North American Menopause Society, one of the most conservative of guideline-publishers and one of the ones to jump most thoroughly on the take-hrt-and-die post-WHI bandwagon, published a new set of menopause treatment guidelines that totally revised their stance on HRT use, even in women with the BRCA mutations and even on use by older women.
Here's an article summarizing the new statement:
Don't Be Nervous About Hormone Therapy for Menopause, Says NAMS (free signup required to read)
And here's The 2017 hormone therapy position statement of The North American Menopause Society in its journal abstract and in full.
First of all, the position paper states its applicability:
The statement as a whole is fairly clearly composed and not difficult to read and we encourage women to read it for themselves. There are key points identified and clearly listed out after each section, and we for the most part agree with all of them. Perhaps startlingly, there's very little in there that's actually new or different from our own understanding, carefully sifted from research and consideration and spelled out here on the site.
Amongst the things that did catch our eye, however, was the reference (p6, vasomotor symptoms) to a 300 mg dose of progesterone:
We're pleased to see that in general, NAMS is distinguishing between the effects of oral as opposed to transdermally-delivered HRTs. This is big, not the least of which is because for years Premarin was taken as being synonymous with all HRTs and thus tarred all HRTs with any effect of either its specific formulation or its delivery route.
We're also pleased that this paper recognizes that women who have a hysterectomy with retained ovaries often experience subsequent early menopause:
And for those who have had an oophorectomy, there is no longer a "wait and see if you need it" (which we've always felt rather meant "demonstrate enough suffering to show you deserve it") aspect. The guidance is clear:
Finally, there is a demonstrated improvement in quality of life with HRT that may make the risks of HRT acceptable. What a notion! Women want to feel well and they're willing to accept some risks to do so. Again, this is quite in keeping with what we have seen women pleading for during the whole WHI brownout on HRT.
In the area of osteoporosis, there are no surprises other than the endorsement of HRT for preserving bone density. Of interest, however, is the statement that "Bone protection dissipates rapidly after HT discontinuation, but no rebound in fracture risk has been found." This suggests that when women finally do decide to quit HRT, they aren't going to immediately shatter. That doesn't negate the need for good bone maintenance practices throughout menopause, but it gives some hope that relinquishing HRT doesn't automatically mean going onto a bisphosphonate.
One important area this position paper identifies and begins to clarify is what women with hormone-related cancers should do.
With respect to genetic risk for cancer,
And this is the summary given of their overall evaluation and advice:
The new NAMS statement includes a lengthy list of endorsements quoted at the end, and we are copying this out just to demonstrate how widespread this revision of the "party" line now is:
The beginning lay, catastrophically, with the cancellation of the Women's Health Initiative Study in 2002. There was a huge worldwide panic in the press, with the end message that using HRTs caused breast cancer. An immediate response followed, in which roughly 50% of the women in the US stopped taking HRT. Over time, attempts were made to suggest other ways of interpreting the data and stances softened, but the basic message persisted: HRT was too dangerous to use.
Whilst HRT supporters continued to explore how hormonal support in menopause, especially surgical menopause, could still be safely used, the costs began to accrue. Studies have suggested that nearly 50,000 women in the US, who were in surgical menopause and quit HRTs because of the study-related panic, died due to that decision.
Further, there were significant fiscal costs both to women and to the general economy from the morbidity due to hot flashes and other untreated menopausal issues. Between 1999 and 2011, says one study:
Women with hot flashes used more healthcare services, particularly outpatient services, than women without symptoms, the researchers found. The extra services added up to $1,336 more per person per year compared to women without symptoms, and the indirect economic loss due to missed work was an extra $770 per woman per year.Additionally, the authors of that study attributed about $300 million in losses per year to untreated hot flashes, and for the full population of the US, expand that loss estimate to $billions. In Europe, a similar study/estimate suggests a loss of more than €100 million per year just in the Netherlands alone.
But misery isn't measured in currency or even deaths alone. The vast number of women untreated and told to swallow their symptoms because they were "just depressed" or otherwise had failed at talking themselves out of anything more than "a few warm spells" (the classic medical description of menopause presented by many doctors) cannot be counted. But we felt it and we saw it in the discussions online amongst the menopause community, as women struggled to make sense of their symptoms in a climate that forbade them treatment and turned the blame back on themselves. At best, we hoped that with time the more sensible interpretations of the study outcome would take hold and those stances would soften in the decades ahead.
A shocking statement
The author was the Principal Investigator for the WHI Vanguard Clinical Center at the University of California, San Diego for the entire primary study period from 1993 through 2005, Chairman of the WHI Principal Investigators Committee from 1994 to 1995, a member of the WHI National Steering Committee from 1994 to 2005, and Chairman of the WHI Observational Study Scientific Advisory Committee from 1996 to 2005.Here's the full citation:
R. D. Langer (2017): The evidence base for HRT: what can we believe?,
Climacteric, DOI: 10.1080/13697137.2017.1280251 (alternate link)
Basically, the author asserts that many of the research team were shut out of the decision to publish the initial WHI results (which resulted in the study cancellation) paper and were given neither time to review the release nor comment upon it. Further, the timing worked out such that the press release came out before anyone capable of reading the results could have access to them. And, finally, the press release itself was manipulated to emphasize the breast cancer risks...even though they did not exist when the data was correctly analyzed. The author summarizes in terminology rare in the medical press:
The unmistakable and deliberate focus of the small group of self-appointed authors was to trumpet a finding of harm from breast cancer – the science and statistics notwithstanding. This was deeply embedded in the paper and emblazoned in the press release.The author concludes:
The WHI trials were soundly designed to address the questions the program was intended to answer, with planned procedures duly noted in the protocol. That good science became distorted and ultimately caused substantial and ongoing harm to women for whom appropriate and beneficial treatment was either stopped or never started. Key faults have included: failure to properly identify the study goals and population characteristics in presenting and interpreting the results; inappropriately generalizing the findings to a key sub-group – newly menopausal women – that was not adequately represented; inappropriately generalizing the findings from specific medications to an entire class; failure to put the findings in the context of existing knowledge (taking the position that the prior studies were simply wrong); favoring publicity, fear and sensationalism over science; and departing from protocol – focusing on unadjusted results, while avoiding planned analyses with proper adjustments and better statistical power.That's pretty powerful stuff, isn't it? Basically, the WHI-mediated panic was an historical blip. But although we saw a followup editorial or two, it certainly escaped notice in the popular press.
Where could we expect to go from there? At the time, in presenting it to our discussion group, we suggested:
As women, we can work to correct the misunderstandings of women and we can bring this review of Langer's to the attention of our doctors when they insist upon the dangers of hrt. It took mere moments for this disaster to unfold upon us women in menopause; it will likely take decades before the damage is undone, especially amongst the doctors who may resist any updating of their opinions.
But then!
Although they released the news on a major US holiday weekend, the North American Menopause Society, one of the most conservative of guideline-publishers and one of the ones to jump most thoroughly on the take-hrt-and-die post-WHI bandwagon, published a new set of menopause treatment guidelines that totally revised their stance on HRT use, even in women with the BRCA mutations and even on use by older women.
Here's an article summarizing the new statement:
Don't Be Nervous About Hormone Therapy for Menopause, Says NAMS (free signup required to read)
And here's The 2017 hormone therapy position statement of The North American Menopause Society in its journal abstract and in full.
What it says
First of all, the position paper states its applicability:
Key to initiating or continuing HT in an individual woman is an understanding of the benefits and risks of age at initiation or time since menopause, specific formulations or types of HT, the duration of therapy, the need for monitoring during therapy, potential risks of continuation, and the need for shared decision making.
The use of HT is considered for different cultural or minority populations of women, including those with surgical menopause, early menopause, or primary ovarian insufficiency (POI) and for women aged older than 65 years.The paper also cites the scientific foundation for its conclusions:
based on material related to methodology, a review of key studies and evidence-based literature, and presentation and synthesis of evidence. It was written after this extensive review of the pertinent literature and includes key points identified during the review process.And they provide another whole document of the actual scientific background, should anyone want to consider the basis for their points. This may not mean a lot to you, but it's part of establishing how and why doctors can take faith in this as "evidence-based medicine." In other words, they've got the evidence in spades...or at least 58 pages worth of it.
The statement as a whole is fairly clearly composed and not difficult to read and we encourage women to read it for themselves. There are key points identified and clearly listed out after each section, and we for the most part agree with all of them. Perhaps startlingly, there's very little in there that's actually new or different from our own understanding, carefully sifted from research and consideration and spelled out here on the site.
Amongst the things that did catch our eye, however, was the reference (p6, vasomotor symptoms) to a 300 mg dose of progesterone:
Micronized progesterone 300 mg nightly significantly decreases VMS (hot flashes and night sweats) compared with placebo and improves sleep. Synthetic progestins have also shown benefit in studies. No long-term study results are available.We're a little wary of that one because of the risk of depression and vertigo with doses like that, not to mention the risk profile suggested in research about breast and cancer risk. For a lot of women, this wouldn't just "improve" sleep; it would be akin to general anesthesia! So we look at the "no long-term study results" as an important flag on this one, not to mention years of women's attempts to follow Dr. John Lee's advice that the more progesterone a woman can take, the better she'll be (spoiler: we have found many women's experiences to disagree strongly with this). In fact, elsewhere in the statement is the concession that high doses of progestins may be associated with depression.
We're pleased to see that in general, NAMS is distinguishing between the effects of oral as opposed to transdermally-delivered HRTs. This is big, not the least of which is because for years Premarin was taken as being synonymous with all HRTs and thus tarred all HRTs with any effect of either its specific formulation or its delivery route.
We're also pleased that this paper recognizes that women who have a hysterectomy with retained ovaries often experience subsequent early menopause:
For women whose ovaries are retained at the time of hysterectomy, there is a two-fold increased risk of ovarian failure, and 20% or more of these women may develop symptoms of diminished ovarian reserve within 1 yearMany women have been denied HRT following a hysterectomy because they nominally still have ovaries. Documenting that those ovaries may experience reduced output can make a great difference for these women. We've known about this statistic for years, but judging by the number of women complaining about this situation, not as many doctors as we might hope do.
And for those who have had an oophorectomy, there is no longer a "wait and see if you need it" (which we've always felt rather meant "demonstrate enough suffering to show you deserve it") aspect. The guidance is clear:
Unless contraindications are present, ET is indicated for women who have had a bilateral oophorectomy and are hypoestrogenic to reduce the risk for VVA and dyspareunia and osteoporosis, with observational data suggesting benefit on atherosclerosis and CVD, and cognitive decline and dementia.The paper notes that estrogen has been demonstrated to reduce joint pains and stiffness. That's something that women have been told for years was not and could not possibly be related to menopause, leading to lengthy diagnostic journeys through the autoimmune disease realm. Once more, women's experiences are validated here, and that should vastly improve our ability to be successful in advocating for and obtaining appropriate treatment.
Finally, there is a demonstrated improvement in quality of life with HRT that may make the risks of HRT acceptable. What a notion! Women want to feel well and they're willing to accept some risks to do so. Again, this is quite in keeping with what we have seen women pleading for during the whole WHI brownout on HRT.
In the area of osteoporosis, there are no surprises other than the endorsement of HRT for preserving bone density. Of interest, however, is the statement that "Bone protection dissipates rapidly after HT discontinuation, but no rebound in fracture risk has been found." This suggests that when women finally do decide to quit HRT, they aren't going to immediately shatter. That doesn't negate the need for good bone maintenance practices throughout menopause, but it gives some hope that relinquishing HRT doesn't automatically mean going onto a bisphosphonate.
One important area this position paper identifies and begins to clarify is what women with hormone-related cancers should do.
For women with breast cancer, low-dose vaginal estrogen should be considered and prescribed in consultation with their oncologists.Note that this doesn't default to an OB-GYN or family doctor. This is specialty territory, and so this is where we need to turn to an oncologist. If you've been forbidden HRT because of a vague "family history" of cancer, you deserve a full and detailed workup of your history and actual genetic risks rather than depending upon something Aunt Martha said once. And if you have been treated or are now being treated for breast cancer and are in pain from GSM (formerly known as vaginal atrophy), this holds out considerable hope that you might be able to use this most effective treatment if nonhormonal measures have been unavailing.
With respect to genetic risk for cancer,
Limited observational evidence suggests that HT use does not further increase risk of breast cancer in women with a family history of breast cancer or in women after oophorectomy for BRCA 1 or 2 gene mutation.But for women who have or who have had breast cancer, the outlook remains unfavorable:
Systemic HT is not recommended for survivors of breast cancer, although selected cases with compelling reasons may be discussed in conjunction with an oncologist after nonhormone options have been unsuccessful.More detailed analysis of risks involved with lung, colon, and ovarian cancer are in the statement, but women concerned about those areas definitely need to read the statement itself.
And this is the summary given of their overall evaluation and advice:
Hormone therapy formulation, dosing, regimen, route of administration, and the timing of initiation of therapy likely produce different effects, although these have yet to be evaluated in head-to-head RCTs, and there is a significant difference in the benefits and risk of estrogen alone compared with estrogen combined with different progestogens, at least as studied in the WHI. The concept of ‘‘lowest dose for the shortest period of time’’ may be inadequate or even harmful for some women. A more fitting concept is ‘‘appropriate dose, duration, regimen, and route of administration.’’ Given the more favorable safety profile of estrogen alone, longer durations may be more appropriate. Risk stratification by age and time since menopause is recommended. Transdermal or lower doses of HT may decrease risk of VTE and stroke.We want to underscore this notion of ‘‘appropriate dose, duration, regimen, and route of administration.’’ This pretty much adopts an individualized evaluation of a woman's situation and goals as the standard, rather than an arbitrary "best" HRT or dose or age guideline. This is big. This is great. This is going to take some work within the fundamentally patriarchal field of medicine, but oh, what a wonderful goal.
And who agrees with it?
The new NAMS statement includes a lengthy list of endorsements quoted at the end, and we are copying this out just to demonstrate how widespread this revision of the "party" line now is:
This NAMS position statement has been endorsed by Academy of Women’s Health, American Association of Clinical Endocrinologists, American Association of Nurse Practitioners, American Medical Women’s Association, American Society for Reproductive Medicine, Asociacio´n Mexicana para el Estudio del Climaterio, Association of Reproductive Health Professionals, Australasian Menopause Society, Chinese Menopause Society, Colegio Mexicano de Especialistas en Ginecologia y Obstetricia, Czech Menopause and Andropause Society, Dominican Menopause Society, European Menopause and Andropause Society, German Menopause Society, Groupe d’e´tudes de la me´nopause et du vieillissement Hormonal, HealthyWomen, Indian Menopause Society, International Menopause Society, International Osteoporosis Foundation, International Society for the Study of Women’s Sexual Health, Israeli Menopause Society, Japan Society of Menopause and Women’s Health, Korean Society of Menopause, Menopause Research Society of Singapore, National Association of Nurse Practitioners in Women’s Health, SOBRAC and FEBRASGO, SIGMA Canadian Menopause Society, Societa` Italiana della Menopausa, Society of Obstetricians and Gynaecologists of Canada, South African Menopause Society, Taiwanese Menopause Society, and the Thai Menopause Society. The American College of Obstetricians and Gynecologists supports the value of this clinical document as an educational tool, June 2017. The British Menopause Society supports this Position Statement.
How will this affect me?
If you're already taking HRT, relax. We still have data that suggests that our lowest effective dose still relates to least risks, especially with regard to combined HRT (estrogen + progestogen). But we also know that "lowest" really means the one that makes us feel the way we define "well" in menopause to be. With the new statement, though, we no longer have to fight off our doctor's insistence that we stop HRT after five years of use (a disastrously simplistic reading of the original WHI study cancellation report) or, really, at any particular age milestone. That cap is lifted and it's now supported that we can continue to reap benefits from ongoing HRT use. We'll still argue that we need to reappraise our level of need for supplementation as we age , but that's just housekeeping.
If you quit HRT and are now thinking about going back on it to regain its benefits, sorry. It's still felt that the evidence is strong enough, even for transdermal HRTs, that they raise clotting risk enough that if we have been off of them for any substantial time (something like a matter of months), our risks upon resuming are not adequately offset by benefits. This may be negotiated according to amount of time and the quality and quantity of our symptoms, though, so it's not yet an absolute ban. We may see this thinking revisited in time and we'll let you know if we see anything that changes that position, but for now, "no" seems to be the authoritative word. But even if we've stopped systemic HRT, don't forget that we can continue using vaginal HRT to support those local tissues and functionality without that concern.
If you want to take HRT and your doctor says no, it's too dangerous and gives you cancer, this statement provides your best argument, hot from the medical press and international approval. But remember, our doctors are busy and even if they have time to read journals, this may still be beyond their usual subscription list. So feel free to share the link to the position statement and call attention to the fact that so many international agencies have endorsed it.
And for the sake of all women in menopause, we can bring this up in conversation. While women often conspire in a general silence about menopause (no, we don't know why and it makes no sense, really), so much of the WHI-related anti-HRT panic was passed along woman-to-woman. So now we can reverse this trend by talking with our fellow women when the topic arises and make sure that if they are not comfortable in their menopause, they know about this latest information on HRT and recommendations for its use. We focused so long on its dangers, and that totally caused everyone to lose sight of its benefits. We finally have solid, science-based ground that we can use to help turn that conversation around.
Subscribe to:
Posts (Atom)