Flaming the fires of HRT: what influences risk?
Let’s face it. Despite my doubts about hormone replacement therapy (HRT), just like the Energizer Bunny, it’s going to keep on going. So as any responsible journalist must do, I have to share the good along with the bad and ugly. The trouble is that data rarely agree, lending confusion to the growing controversy about health risks, appropriate timing, combination and use of HRT.
Last week, several of you sent me a link to a study in the current issue of Menopause that appears to further clarify use of HRT and heart disease risk. Quite honestly, I had seen the study but was hesitant to write about it for fear of simply fueling the fires. But you’ve asked so I’ve answered.
The investigators of this particular study note that experts suspect that timing of hormone replacement, i.e. age when it’s started or time since menopause has begun when it’s started, plays a role in some of the differences between previous reports on HRT and heart disease. For example, reanalysis of data from the Nurses Health Study demonstrates that any heart benefits of HRT rely on starting therapy within 10 years of menopause, while data from the Women’s Health Initiative show that younger age plays an important role as well.
In a quest to tease this out further, they examined information on deaths from ischemic heart disease, age at first and/or current use of HRT, prior use and duration of use in 71,237 postmenopausal women in the California Teachers Study over a period of approximately 9 years. The findings?
- Overall, current age while using HRT appears to influence risk of dying from any cause. This factor appears to be much more importan than age that HRT was started or years since menopause began. Indeed, women using HRT at the time of the study who were younger than 65 years were found to have a 45% reduced risk of death from any cause compared to women who had never used HRT.
- Similar findings were seen when the researchers examined death from heart disease, with HRT providing some protection in younger current users that virtually disappeared once they reached 75 years.
The upshot is that the health consequences and risks of HRT may be influenced most by age at current use, with younger women having the most benefits to gain. Any sort of protection starts to disappear as women grow older so the window of opportunity might be small.
Still, questions remain. These researchers were only trying to determine the most important influencer(s) of death from heart disease and not examining cancer or other risks that have been definitively demonstrated. Do these data fan the controversial fires and serve to heat up the debate? I believe that they do.
As always, buyer beware. Nothing is ever as it seems. Especially when it comes to hormone replacement therapy.
Read MoreHormone replacement therapy…timing is everything, right?
Hormone replacement therapy (HRT) continues to be a hot topic in the menopausal world. And no wonder! Because the deeper we dive into the controversies, the more information we seem to learn about its dangers.
If you search for hormone replacement or HRT on this blog, you’ll find that the dialogue has nothing but consistent. And while naysayers may try to accuse me of a personal vendetta against hormones, it’s actually not the case. I started Flashfree for several reasons, the most important being that I wanted to provide enough information about menopause and aging and treatment strategies to enable women to think on their feet, consider the facts and have intelligent dialogues with their peers and practitioners before making any decisions that could affect their health and wellbeing as they grow older. Moreover, although I am a strong proponent of alternative strategies to combat the unpleasantries of dwindling hormones, I still believe strongly in the benefits of certain Western approaches to treating illness. However, I also a strong believer in integrative strategies that combine the best of our knowledge in an individualized fashion; my mantra is ‘treat the individual, not the masses.’ Hence, when I read about the history of the menopause in general and HRT in particular, what I see is disease mongering at its finest, examples of fear and loathing and mostly, a disrespect of women. And I care too much about women’s health to remain silent.
Last Friday, several of my colleagues sent me a link to the following study:
“Breast cancer risk in relation to the interval between menopause and starting hormone therapy.”
This newly-published study in the Journal of the National Cancer Institute is one of the largest to date since the findings of the now infamous Women’s Health Initiative (WHI) study linking Preempro to breast cancer. In it, investigators used observational information culled from over a million postmenopausal women in the United Kingdom to determine how type and timing of hormone therapy might influence the risk of developing breast cancer.
A bit of context is necessary for those of you who are unfamiliar with the major criticisms of WHI, namely that that the women studied were not representative of the normal menopausal population, were older, started hormone therapy later in life (i.e. >5 years from when menopause started) when their risks for disease were greater, and that the type of hormone replacement, namely the progestin component, were not taken into consideration. WHI was also criticized for not focusing on the small percentage of women in the study who took estrogen-only and were not at greater risk for breast cancer. (If you want to read more about that particular issue, check out the write up on data presented at this past year’s San Antonio Breast Cancer Conference.)
In the UK study, the average age of participants was 56.6, considerably younger than the study population in WHI. More than half (55%) of participants reported having used hormones at some point and 35% were current users, and the rest, had never used hormone therapy. Study participants were matched by socioeconomic status, childbirth information, BMI, physical activity, alcohol consumption and smoking to insure that these factors did not influence the study findings.
Overall, 15,759 breast cancers developed and were diagnosed approximately a year and a half after the last point of contact:
- Despite contentions by some experts that starting combination hormonal therapy within 5 years of menopause is safe, women between the ages of 50 and 50 who began HRT less than 5 years after menopause had the highest rates per year of breast cancer — .61% per year — that twice that of women who had never used hormones (.31%).
- Current users of estrogen also demonstrated increased breast cancer rates (.43%) who started hormones within or less than 5 years after menopause started.
- The risk of developing breast cancer was roughly 1.5 times higher among women on combination hormone therapy who started within 5 years than women who started 5 year or more from menopause.
- The risk of developing breast cancer among past users of hormonal therapy tended to decline over time after use of hormones stopped, and within 14 years, were almost equivalent to never users.
Mind you, the study is not without fault and may be criticized on the basis of the fact that it relied on observational information rather than randomized controlled results. In other words, data were collected and then analyzed based on what they inferred. The research might also be questioned due to the fact that information about use of hormones was reported over a year before cancer was diagnosed, thereby possibly leading to mischaracterization of hormone users/non users and estimates of the risk for developing breast cancer. Nevertheless, the researchers say that taking these factors into account, breast cancer risk among hormone users regardless of type, would have increased by a factor of at least 1.2.
The key take-away message from this new study is that it’s may be impossible to define the safest parameter for using hormone therapy. For certain women, HRT may never be safe. For others who are willing to risk life-threatening conditions for fewer hot flashes, HRT may be worth the gamble. As always, ask the hard questions.
Timing is everything, right? Maybe not when it comes to hormone replacement.
Read MoreEstrogen only? Fanning the flames of the HRT debate
A study presented at the esteemed San Antonio Breast Cancer Symposium last week has fanned the flames about the benefits versus risks of hormone replacement for menopausal symptoms. In this study, which ironically was pulled from the site press release highlights after experts questioned its merit, researchers did a reanalysis of data from the Women’s Health Initiative trial, the infamous 2002 study that was halted after Preempro was shown to increase breast cancer risk. Their findings? That women who had participated in the estrogen only arm of the study, had had benign breast disease, had had hysterectomies and had family histories of no breast cancer actually had significant reductions in breast cancer incidence. What’s more, 75% of women who did not have benign breast disease at the study’s start also had a reduced risk of developing breast cancer.
So, this is good news, right?
Well, estrogen alone can only be used by women who have had hysterectomies; estrogen plus progestin is used in women with intact uteri in order to avoid uterine cancer. This means that only a subset of women with menopausal symptoms are eligible to use estrogen alone. Moreover, as a physician blogger points out, the findings run counter to most data that show that estrogen use is actually associated with an increased risk of breast cancer. He also notes that abstracts that are accepted as posters at major medical meetings often have flawed or spotty data; in fact, in my years as a medical writer, I’ve often run across abstracts that ultimately disagree with published works.
The bottom line here is that despite the news, using estrogen alone to treat menopausal symptoms might only be an option for a very small percentage of women and may still place them at risk for cancer. At the end of the day, prescribing hormone replacement therapy continues to challenge the Hippocratic Oath: first do no harm.
Read MoreHRT – Put up your dukes
Ladies (and gents)…in this corner, weighing in with fear, loathing and disease-mongering, hormone replacement therapy (HRT). And in the other – weighing in as ‘snake oil,’ everything that “doesn’t work,” remains “unproven,” is “unsafe,” hasn’t been approved by the Food & Drug Administration, alternative strategies. Put up your dukes!
Sounds like a boxing match without a referee, eh?
Adding to the controversy are recent study findings showing that Pfizer’s Preempro (estrogen plus progestin) HRT may increase the risk of aggressive, invasive breast cancer and deaths from breast cancer in some women. In fact, the lines continue to be drawn between those who will fight for their hormones no matter what and individuals who believe that either greater regulation is needed or that hormones should be taken off the market altogether. It reminds me of the controversy over mammography, which has been not been proven to decrease breast cancer rates or improve survival. That’s a post for another day, although I encourage you to check out the posts that my friend Marya has written.
The argument against using the Women’s Health Initiative Study (WHI) data to demonstrate the dangers of HRT focuses on the small percentage of women enrolled in the original study who were in the age group (5o to 54 years) when women would be starting hormone therapy. Indeed, research shows that in addition to the type of progesterone added to estrogen, the time on hormone therapy can significantly influence health risks. Moreover, in the WHI, women who took estrogen only were not shown to have increased breast cancer risk (but a heck of a lot other increased risks – just look at the data). And yet, after the WHI hormone study was halted in 2002, substantial declines in the rates of breast cancer were noted in numerous countries, including Canada and the United States. Adding fodder, many pro-HRT experts argue that the alternatives – bioidenticals or complementary medicine – are unproven and downright unsafe.
In case you’ve not been reading this blog regularly, I believe the following and wrote it to a very passionate reader of HealthNewsReview Blog who felt that I was marginalizing women’s suffering:
For decades, women have been duped into believing that menopause is a disease that requires medical treatment, but at the same time, researchers have been unable to differentiate many of its symptoms from those of aging. Consequently, it’s imperative not only to ask what we are treating but why and how.
By all means, if you are comfortable with HRT and other treatments, go for it. But use them with eyes wide open and always examine the risks versus benefits. You might be surprised by what you learn. And how much we still don’t know.
I recently ran across the following statement with regards to the confusion:
“Some things don’t need to be healed; they just need to progress naturally.”
When you’re down for the count, sweating and flashing and swinging without a referee, the call about HRT can be a tough call to make. The good news? Menopause won’t kill you and symptoms do eventually go away. It is just one more of life’s transitions that we have to navigate. Just try to steer yourself towards informed choices and decisions and always, ask the hard questions. There are always those who ‘do,’ and those who ‘don’t.’ Just be sure you’re doing or not for the right reasons.
HRT and breast cancer – more red flags
More bad news from the Women’s Health Initiative study and hormone replacement therapy (HRT, combined estrogen and progestin) front: not only does combined HRT appear to double the risk for breast cancer in some women, but these cancers are more invasive/agressive and more likely to lead to death.
The WHI findings have been repeatedly criticized by HRT advocates, who claim that the the women who were studied were not representative of the typical menopausal population, e.g. they were older and well past menopause at enrollment. So it is true that the potential benefits of HRT that might have been experienced by younger women were not explored. Indeed, time on hormones and the relationship between hormone use and how far into menopause a woman is can influence risk, as can the progestagen component. (If you want to read more about these specific factors, click on the links.) Nevertheless, what is also clear is that following the 2002 findings and the significant decline in HRT prescriptions, a substantial decrease in breast cancer rates were observed in both the US and Canada, so much so that the Canadian Cancer Society recently recommended that HRT be taken only as a last resort.
And the latest study findings?
In their continuing quest to determine insights into the risk-benefit ratio of HRT, researchers continued to follow and evaluate data from 83% (12,788) original trial participants. They found that HRT increased the incidence of invasive breast cancers by as much as 8% (compared with placebo), and that these cancers were also likelier to spread to the lymph nodes (24% of women taking HRT were found to have lymph node tumors compared to 16% of women taking placebo). Moreover, twice as many women on HRT died as the result of their cancer.
In an accompanying editorial, Dr. Peter Bach, a health outcomes researcher from Sloan-Kettering Medical Center in New York City, suggests that the latest study findings may only be the tip of the iceberg and that “it is possible that the increase in breast cancer deaths due to hormone therapy has been underestimated in the current study and that with longer follow-up, the deleterious effect will appear larger.” Additionally, he notes that “available data dictate caution in the current approach to hormone therapy, particularly because one of the lessons from the WHI is that physicians are ill-equipped to anticipate the effects of hormone therapy on long-term health.” Nor, have short-term approaches to hormone therapy been proven in clinical trials. As Dr. Bach points out, how can practitioners help patients make informed decisions if they are ill-informed themselves and the information, “speculative.” Nevertheless, the North American Menopause Society is taking the opposite stance, stating that ” clinicians can help women put the breast cancer risk into perspective by informing them that the increased risk of breast cancer using estrogen plus progestogen for 5 years is very similar to the increased risk of breast cancer associated with having menopause 5 years later. This increased risk of breast cancer occurs with a woman’s own internal, natural estrogen and progesterone.”
If this study and its accompanying editorial don’t raise a few flags, nothing will. And despite the pro-HRT stance of the North American Menopause Society, I encourage all women to start educating themselves before making the HRT leap. What’s more, be aware that once you start taking hormones, your practitioner might not be able to provide evidenced-based information on how to stop them, should you decide that they are not for you.
Ask yourselves, what is the trade-off here?
(Reuters Health, as usual, has a few more gems from this study that are required reading. You can find them here.)
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