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.
