Soy. Is it safe?
For years, researchers have been exploring the potential of soy isoflavones — naturally-occurring plant estrogens — for alleviating menopausal symptoms such as hot flashes, atrophy and bone loss. Thus far, certain components of soy, including genestein and S-equol have shown the most promise. However, are they safe? And, as the adoption of soy as a viable alternative to risk-ridden hormone replacement therapy continues to grow, and women turn to supplements rather than food-based soy, is there anything that they need to worry about in terms of side effects?
Researchers recently evaluated this question in a study of 403 postmenopausal women who took either 80 mg soy tablets, 120 mg soy tablets or placebo tablet daily for two years. The particular type of soy isoflavones used were hypocotyl isoflavones, which are a byproduct of soy protein and (very rich in daidzein – the second most plentiful isoflavone in soy. The effects of the supplements were measured at the study’s start, at one year and at the end via blood tests and a well-woman examination (i.e. mammogram, pap smear, x-rays to measure bone density). A smaller group of women also had ultrasounds done to determine any possible effects on the lining of the uterus or development of fibroids.
Although the primary goal of the study was to determine the effects of this type of soy supplement on osteoporosis and bone loss, the researchers discovered that taking soy supplements during this time period did not present any major risk to health and did not affect thyroid function. Although one participant developed breast cancer during the study and one, endometrial cancer, 1) utrasounds in the subgroup of women who received them did not show any uterine thickening and 2) the rate of cancer development in this study, only two women over a two year time period, was considerably lower than statistically likely in a general population of women. Both of these factors support the contention that soy isoflavones are not likely to promote either cancers.
So, is soy safe over the long-term? It appears that it is. HOWEVER, bear in mind that the type of soy used in this study is are very different that the type that is commonly sold over the counter, which commonly contain higher percentages of genistein, the most plentiful isoflavone component in soy.
And what about osteoporosis? This particular paper did not address those specific results, although others have. Thus far, the results have been mixed. However, this particular study, better known as OPUS (Osteoporosis Prevention Using Soy)is one of the largest and most comprehensive to date and those findings are likely to come to light soon.
In the interim, if you are going to be taking soy in supplement form, be mindful that your exposure is likely to be as one to four times that a typical Asian diet and as much as 100 times that of a typical Western diet. While these level do not appear to be harmful, herbal and plant medicines are not without risk so as always, the rule of thumb is be vigilant and speak to a health practitioner first.
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 MoreWednesday Bubble: Playing Russian Roulette – Hormone Replacement & Ovarian Cancer
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.
Read MoreHRT 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.)
Read MoreNewsFlash: Canadian Cancer Society Recommends Against HRT Use Except as Last Resort
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.