HRT

Danger! Danger! HRT prescribing lagging behind recommendations

Posted by Liz on Dec 6, 2010 in HRT | 0 comments

[youtube=http://www.youtube.com/watch?v=RG0ochx16Dg]

Here’s a disturbing piece of news:

Stanford University School of Medicine researchers are reporting that when it comes to prescribing practices, physicians across the country continue to lag behind recommendations from FDA and other organizations cautioning that hormone replacement therapy (HRT) should be used at the lowest dose and shortest period of time possible or only as a last resort. This, despite accruing evidence warning of the dangers of hormone therapy.

While use of hormonal therapy has gradually declined ,some 6 million women continue to place themselves at risk annually. This risk appears to be somewhat exacerbated by the fact that that their doctors, especially ob/gyns, have not changed their prescribing habits very much. Indeed, less than a third of hormone therapy users surveyed in the IMS National Disease and Therapeutic index (which formed the basis for this latest bit of information) were given prescriptions for lower-dose hormone pills, vaginal suppositories or patches. Especially at risk are women old than 60 years in whom the risk/benefit of HRT is very unbalanced, more than a third of whom continue to use hormonal therapy to address symptoms. Thankfully, however, women younger than 50 and up to age 59 appear to be paying attention to the headlines and giving up hormones altogether.

Although the reasons that doctors aren’t paying attention are unclear, the researchers suggest that perhaps clinical practice has not caught up with data or that older women in particular, are satisfied with symptom control and don’t want to rock the boat.  Or perhaps many women in this age group remain unaware of the increased risk of heart disease and breast cancer (among others) associated with menopausal hormonal therapy. Regardless, the message isn’t getting through.

How do you change prescribing habits when there’s a breakdown in communications or when study investigators suggest that “it takes a huge event to change clinical practice?”  A huge event? I don’t know about you but I think that increases in heart disease and cancer risks are pretty big events. Ladies – it’s time to take this matter into your own hands. Speak up. Work with your doctor, discuss the treatment strategy he or she is recommending and especially when it comes to HRT, ask the hard questions.

Right now, like Robot from ‘Lost in Space,’ I don’t think that we can accept any other course of action other than to take action.

Wednesday Bubble: Playing Russian Roulette – Hormone Replacement & Ovarian Cancer

Posted by Liz on Nov 10, 2010 in HRT | 6 comments

Do we really need to burst another hormone therapy bubble? Or have you heard enough yet? If you are anything like me, I remain puzzled by those in the pro-HRT camp that keep on insisting that the data are incorrect and that hormone replacement therapy (HRT) is safe. Just last week I received a press release stating the following:

“Medical Experts Report Reduced Risk of Life-Threatening Diseases in Women Who Undergo Menopause Hormone Therapy…Menopause experts Drs. Lovera W. Miller and David C. Miller, claim in their new book, Womenopause: Stop Pausing and Start Living (O Books 2010), that Menopausal Hormone Therapy, or MHT, can help reduce the risk of serious health conditions such as heart disease, stroke, breast cancer, diabetes, and even depression and dementia. The Millers present new evidence that puts to rest the controversial statement by the Women’s Health Initiative (WHI) in 2002 that declared MHT (formerly known as Hormone Replacement Therapy, or HRT) was harmful and could lead to the same health risks that the doctors say it now helps prevent.”

The Miller present new evidence that puts to rest the contention that HRT is harmful. Really?!

Ironically, the very same day, I received word of data presented at the American Association for Cancer Research Frontiers in Cancer Prevention Research Conference this week demonstrating that both combination hormone replacement therapy (estrogen plus progestin) and estrogen-only hormone therapy increases the risk for developing ovarian cancer. Previous studies have linked the use of estrogen only hormone therapy to ovarian cancer so these findings are important.

This latest bit of information comes out of a European study of almost 127,000 women, 424 of whom developed ovarian cancer after 9 years of followup. Among current users of hormones during the start of the study, 69% used combination HRT and 18%, estrogen-only hormone therapy. Key findings included:

• Increasing duration of use of any hormones was linked to an increased risk for ovarian cancer; women who used hormone therapy for 5 years or more had a 45% increased risk compared to women who had never used any hormones.
• Current use of any types of hormones was associated with an overall 29% increased risk for ovarian cancer.
• Type of hormone (combination versus estrogen only, regimens, how administered, as well as body-mass-index, smoking, oral contraceptive use and pregnancy history did not significantly affect risk.

In an accompanying news release, the lead investigator is quoted as suggesting that the link to ovarian cancer is consistent with recommendations that if women are going to choose to take hormones, that they take them for the shortest period of time possible.

This study joins the evolving database of evidence demonstrating that hormone replacement therapy, whether it’s combination estrogen/progestin or estrogen-only, can be a risky proposition in certain women. Want to read more trigger pulling data?

• HRT & Breast Cancer…  more and even more and don’t forget
• HRT & Death from Lung Cancer…  and more
• HRT & Heart Disease… and more

I don’t know about you but this woman is staying clear of HRT, hot flashes or not.

HRT and breast cancer – more red flags

Posted by Liz 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.)

Wednesday Bubble: HRT? Everybody must get kidney-stoned

Posted by Liz on Oct 13, 2010 in HRT, Uncategorized | 0 comments

[youtube=http://www.youtube.com/watch?v=skOKkBqxGcE]

Everybody must get stoned?  If you are using HRT, this may be the case. Straight out of the headlines of the American Medical Association’s Archives of Internal Medicine: Healthy women who use HRT may be at increased risk of kidney stones.

You hear about them. But what are kidney stones?

Kidney stones are hard masses the develop when crystals separate out from the urine. Many factors interact to form stone and they are influenced by both genetics and the environment. Although they are often prevented by naturally occurring chemicals before they actually form, when they occur, they can cause extreme pain. Over time, they may actually damage the kidneys. And while kidney stones more commonly affect more men than women up to a certain age, by the time a woman reaches 50, this discrepancy balances out, possibly because estrogen may have a protective effect up until this time.

So, if estrogen is good and protective, what goes wrong when you add it back to the mix?

The findings...In the latest analysis of what is now becoming the infamous Women’s Health Initiative Study, researchers evaluated over 10,000 women in natural menopause who had taken estrogen only (Premarin), estrogen plus progestin (Preempro) or placebo. After an average of 5 to 7 years (depending on which agent the women were taking), women taking hormones, either alone or in combination, had a 21% increased risk of developing kidney stones. When the researchers excluded women who stopped using hormones during the actual trial from the analysis, the likelihood of developing kidney stones increased to 39%. Moreover, study researchers were unable to attribute the increased risk to any other factors, including age, ethnicity, BMI, prior use of hormones or intake of coffee or thyroid medication. Writing in Annals, however, they did note that the way that kidneys stone are formed is complex, and that estrogen may play a role in several stages of that formation and requires further study.

According to the researchers, about 5% to 7% of women reaching menopause will develop kidney stones. My friends over at Reuters health, who did an excellent recap of this study, note that in combination with hormone therapy, this risk increases up to 10%, despite that addition of progestin.

In addition to avoiding hormone therapy, the best thing to do to prevent kidney stones is to hydrate! If you have a tendency to form stones, the National Institute of Diabetes and Digestive and Kidney diseases recommends that you drink enough fluids, preferably water, to produce about 2 quarts of urine a day. Changing your diet can help too: some experts recommend limiting dairy and proteins that are high in calcium. The best thing to do, as always, is to do some preliminary research and then contact your health practitioner.

So getting stoned? How about losing the HRT? Another bubble burst for a failed therapy.

NewsFlash: Canadian Cancer Society Recommends Against HRT Use Except as Last Resort

Posted by Liz on Oct 1, 2010 in breast cancer, HRT | 2 comments

Researchers and representatives comprising the Canadian Cancer Society are recommending that women avoid taking hormone replacement therapy or HRT for any reason other than relief of severe menopausal symptoms that have not responded to other treatments. Wow! Talk about a newsflash!

The reason for last week’s statement is a new study published online in the Journal of the National Cancer Institute that demonstrates an almost 10% decline in the rate of breast cancer among Canadian women between the ages of 50 and 69 following a drop in HRT use.

Utilizing data on HRT prescriptions, incidence of breast cancer, mammography and HRT use in 1,200 women between the ages of 50 and 69, considered primary users of HRT, to a 9.6% decline in the incidence of breast cancer between the years 2002 and 2004. Comparatively, rates during the period of time just before the time studied, i.e. 1998 and 2001, had declined by less than 1%. Incidentally, the more than 50% drop in use of HRT during this time period directly followed reports from the Women’s Health Initiative Study showing a increased risk of stroke, heart attack and breast cancer among users of HRT. Moreover, researchers found that the decline in breast cancer cases were not the result of fewer women getting mammograms; in fact, mammography rates remained stable during this time period.

The researchers say that their results, which are the first in Canada to examine the potential link between widespread declines in HRT use and breast cancer among postmenopausal women, support the Society’s goal of providing Canadian women with information about how to reduce their risk of developing breast cancer. Although the study findings may possibly be limited by the fact that the rely on self-reports of use of HRT and do not take into consieration how often and for how long HRT was used,  the researchers claim that the results provide meaningful information on factors that influence breast cancer. Now, they need to determine if HRT promotes or causes breast cancer.

When I asked for a statement from lead study investigator Dr. Prithwish De, he said: “The Canadian Cancer Society’s ongoing review of the evidence on HRT and breast cancer since 2003 led us to our current position and the research study findings reaffirm this position. The Society recommends that women avoid taking HRT for any reason other than to relieve severe menopausal symptoms that have not responded to other treatment. We understand that each woman’s experience with menopause is unique. If, after consulting with their healthcare professional, a woman decides to take HRT, it should be the lowest effective dose for the shortest time possible.”

October is breast cancer awareness month. Educate yourselves and those around you.

Soy! Everything you wanted to know. Or should.

Posted by Liz on Sep 20, 2010 in hot flash, HRT | 6 comments

Confusion about soy abounds. Does it help hot flashes, improve bone health or prevent heart disease by lowering cholesterol? Or it is no more effective than placebo?  Does its effectiveness rely upon the ratio of certain isoflavones — the plant-based estrogen-like components, which in soy include  genistein (50-55% of total isoflavone content of soy), daidzein (40% to 45% of total isoflavone content) and glyceitein (5% to 10% of total isoflavone content) — or is the metabolite S-equol the only component that will yield estrogen-like benefits without negative health risks?

Are you perplexed? I sure am, which is why this particular post may be a bit to scientific for a few and too long for others. however, it’s important to understand some of the reasons why soy continues to intrigue, baffle and well, show differing results in terms of benefits for menopausal symptoms. So I encourage you to bear with me.

I’ve written previously that there are several key reasons why researchers have yet to make any any definitive conclusions about soy during menopause, such as poorly designed studies, small number of study participants, wide range of ages and years from menopause, and the fact that the pros and cons of an agent or strategy are not being studied for a long enough period of time. In other cases, there is an inconsistency in the soy preparation being studied and the ratio of isoflavones may differ; alternatively, researchers have not accounted for the presence of other isoflavones in the diet, which may influence results.

Does a new study that appears in the advanced online edition of Maturitas journal, comparing low-dose hormone therapy to soy powder in women with hot flashes, offer any anything more definitive or different than what’s gone before?

Briefly:

The 16-week study enrolled 60 women between the ages of 40 and 60, all of whom had had their last period at least 12 months, had the same frequency of hot flashes (more than 8 per 24 hours), had not used any hormonal treatment in the 6 months leading up to the study period, and were not currently using any drugs that lower blood fats, treat diabetes, taking other soy-based products or using herbal supplements.

Women participating in the study were randomly assigned:

1. low-dose hormone therapy (a Activelle ®tablet daily, better known as Activella® in the US) plus a placebo powder or
2. 2 portions daily of dietary soy supplementation powder (comprising 45 mg isoflavone per dose) plus a placebo tablet, or
3. 1 placebo tablet/2 portions placebo powder.

All women were first screened  for  current hormone levels, reproductive history, age at menopause, time since menopause, medication use and cigarette/alcohol consumption. During the study, they were asked to use a standardized scale to evaluate menopausal symptoms (hot flashes, heart discomfort, sleep, and muscle and joint problems) mood (depression, irritability, anxiety, physical/mental exhaustion) and sexual problems, bladder problems and vaginal dryness.

The results?

Both hormone therapy and soy supplementation were associated with significant improvements in hot flashes and joint/muscle pain (which declined by about 45.6% in the hormone group and 49.8% in the soy group) and in vaginal dryness (which decline d by 38.6% in the hormone group and 31.2% in the soy group) compared to women who took placebo. Improvements in mood scores were consistent between the three groups, indicating that other factors, such as caring and attention by medical practitioners throughout the study, may have played some role in wellbeing. Moreover, both treatments were considered safe with few side effects.

These results are quite promising, as they indicate that soy may indeed, offer an alternative to hormone therapy in menopausal women seeking relief. However, it’s important to consider the following:

• Like many of its predecessors, the study is a small one.
• The study length was short, lasting only 16 weeks, which some critics might say is too short a time period to elicit a satisfactory clinical response.
• The researchers did not analyze whether or not the women actually took the drugs or soy consistently, and relied on their self-reports.

On the other hand:

• The study followed strict Western scientific guidelines and the women and the researchers did not know who was taking what.
• Symptoms were measured using a common quality of life scale whose goal it is to diminish errors by healthcare practitioners when analyzing results of questionnaires. This particular scale, better known as the MRS, is widely used and allows researchers to evaluate symptoms and treatment over time.

There has been a lot of criticism geared towards alternative treatments, such as acupuncture, herbs and Chinese medicine, as being shams, especially because there is no evidence supporting their use for addressing troublesome menopausal symptoms. Others will claim that the placebo effect is at play, i.e. a situation in which symptoms are relieved by an otherwise ineffective treatment due to expectations or beliefs. However, the researchers of this particular study point to the placebo effect in studies comparing estrogen to placebo, demonstrating for example, a 75% reduction in hot flashes among hormone users compared to a 57% reduction in hot flashes among women taking placebo.

The most important conclusion to be drawn is that there is early evidence that soy supplementation may be as effective as low-dose hormonal therapy in relieving certain vasomotor symptoms and possibly, vaginal dryness. We need more studies like this one, enrolling larger numbers of women, in order to definitively demonstrate benefit. Dollar for dollar, the monthly difference between the two treatments may only be about $30.  Yet, this is one of the first studies I’ve seen that followed enough rules to quiet the rioters. And that alone, is worth the price of admission.

Stay tuned. The fat lady hasn’t sung her soy aria as of yet.

[Special thanks to Reuters Health Executive Editor Ivan Oransky, for your continued support of my mission to provide timely, evidence-based information on menopause and midlife to my readers.]