Posts Tagged "Women’s Health Initiative"

HRT – Put up your dukes

Posted by on Oct 25, 2010 in Uncategorized | 0 comments

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.


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HRT and breast cancer – more red flags

Posted by on Oct 22, 2010 in breast cancer, HRT | 2 comments

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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Wednesday Bubble: HRT – wait a moment!

Posted by on Jun 16, 2010 in HRT | 0 comments

Back in early May, I wrote a post about the difficulties in stopping hormone replacement therapy (HRT) and the disturbing fact that doctors have no guidelines to follow in order to advise their patients on the best strategies. Today’s Bubble is a perfect companion to that piece, as it addresses the fact that research now shows that women who start HRT and then stop it have a tendency to have significantly greater and more severe  menopausal symptoms than had they never started HRT at all.

Writing in the online edition of Menopause journal, researchers say that among 3,496 postmenopausal women who completed a pre- and post- stopping therapy survey during the Women’s Health Initiative study (a trial that compared estrogen/progestin to placebo and was subsequently halted when HRT was found to double the risk of breast cancer) :

  • Those who had not reported having hot flashes at the start of the study were more than five times as likely to report moderate to severe hot flashes after stopping HRT compared with women with no symptoms who took sugar placebo pills. However, women who had reported having hot flashes at the study’s start were only slightly more likely to report hot flashes after stopping HRT
  • A similar pattern was seen for night sweats, i.e. women who had none at the study’s start were almost twice as likely to report them after stopping HRT
  • Age at stopping HRT was increasingly associated with more joint pain, i.e. the older the woman, the higher the risk for experiencing joint pain

The researchers say that although there have been previous reports of  a surge in vasomotor symptoms like flashes and sweats after stopping HRT, these findings show that estrogen, either alone or with progestin, may promote symptoms when HRT is stopped, even if a woman was not experiencing them when she started therapy. More specifically, the risk for menopausal vasomotor symptoms and joint stiffness is four to seven times more in women with and without prior symptoms when HRT is stopped.

The takeaway message is that it’s not only important to consider the health risks associated with HRT but also, what happens when you stop it. Clearly, even if your symptoms disappear while on HRT, your risk for symptoms after stopping therapy is fairly high.

You should always weigh the risk benefit ratio before starting any type of therapy. HRT may not be worth the trouble. Or the multiple risks.

p.s. More on this study from my friends at Reuters Health.

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HRT – How do you stop?

Posted by on May 10, 2010 in HRT | 15 comments

A Twitter friend recently asked me about stopping hormone replacement therapy  (HRT). It was a question that I hadn’t explored on this blog. Although the foundation of Flashfree is to provide information about alternatives to HRT, I’ve never really considered the “what now” of the issue, as in, what if you decide to go off hormones or try alternatives after you’ve been on HRT? So this post is dedicated to her, and to those of you who want to know if there is a safe and effective way that HRT should be stopped.

Interestingly, when I looked into the issue, the answer seemed to be even less clearcut than the therapy. In fact, there are no guidelines for stopping HRT.  To be honest, this disturbs me quite a bit; don’t you believe that if a physician is going to recommend that you take hormones, that he or she should have some clear guidelines as to how to take you off of them? Granted, until the Women’s Health Initiative started to reveal the dangers and risks of HRT, there was no real reason to stop therapy, (although, I’m of the mindset that there’s really no good reason to start HRT).

Fortunately, researchers are finally starting to look into this issue although study findings (which are published in the online edition of Menopause) highlight that the practice of stopping HRT is intuitive and not evidence-based.

So, what did they learn?

Among 438 group practice physicians surveyed, an overwhelming majority believed that women should taper HRT, with most believing that the best strategy was not only to slowly decrease the dose, but also to reduce the number of days HRT was taken per week. However, they had no suggestions with regards to how to taper use of HRT patches, even though the patch is increasingly being recommended and touted as a safe solution to oral hormone therapy. (Notably, like the evidence from this particular study I am talking about, the evidence that shows the safety aspect of the HRT patch is mostly observational, meaning that it is subject to personal bias.)

More interesting, however, was the finding that the majority of the physicians who participated in the study were more strongly influenced by their personal beliefs than by colleagues’ actions or most importantly, by a woman’s preference. In other words, physicians are not asking their patients about what they would like or if they have any thoughts about stopping therapy. More shocking was the fact that only 2% of physicians surveyed relied on actual evidence to stop hormone therapy. Physicians who indicated that they believed that some action should be taken if symptoms returned after stopping hormones overwhelmingly turned to behavioral changes or exercise, not  to alternative therapies such as herbs.

In an era of evidence-based medicine and strategies that integrate eastern and western philosophies, why are our physicians relying on their own personal belief systems rather than real facts? Why aren’t they asking their patients how they feel about stopping therapy or if they have fears about symptoms returning and then thoroughly exploring alternatives with them.  Are these findings in a vacuum or will they be found on a broader basis?  Does the problem lie in fact that there are no standards?  What’s more, why hasn’t the American Medical Association or American College of Obstetrics & Gynecology devised guidelines for stopping HRT therapy? Why hasn’t the Food & Drug Administration demanded this guidance in labeling?

Finally, why do we continue to play Russian Roulette when it comes to women’s health? Isn’t it time for a change?

Let’s start with HRT. There are a lot of folks out there who continue to espouse the benefits, deny the risks and ignore the facts. Clearly, this story continues to unfold. Unsafe medical practices are even more unsafe when they are not backed by evidence, right? Is HRT the exception?  What do you think?

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Wednesday Bubble: Another nail in the coffin for HRT

Posted by on Feb 17, 2010 in heart disease, HRT | 2 comments

Still hearing that HRT can’t hurt your heart? Findings from yet another study, this time published in the February 16 edition of Annals of Internal Medicine, confirm the dangers that HRT poses to your heart, especially in the short-term.

In this latest analysis, researchers evaluated data derived from 16,608 postmenopausal women enrolled in the Women’s Health Initiative trial who still had their uterus. The findings?

Compared to women who had never used hormone replacement therapy, those who had used it continuously over 10 years had more than twice the risk of developing heart disease over the first 2 years, and more than 1.5 times the risk over the subsequent 8 years. For women who started hormone therapy after 10 years of entering menopause, there was also a trend towards developing heart disease over the first 2 years. Of note, researchers did observe a possible protective effect after 6 years in the women who started therapy closer to menopause as risk did start to level off at this time.

The upshot is that the first two years of taking HRT can be a dangerous time for women regardless of whether they start hormones closer to menopause.

Another nail? Yes, I’d say so.

But don’t take my word for it. Knowledge is power. Educate yourselves. And if you’d like to learn more about heart disease and menopause, I’ve written about it numerous times on this blog. I also encourage you to visit the American Heart Association website. Finally, I’d love for you to take a stand. Don’t you think it’s time for the FDA to start paying attention? These drugs are dangerous for women. Yet, they remain on the market and are prescribed daily. Whose nail, whose coffin?

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