Wednesday Bubble: R.I.S.E and shine: help me help you burst the mysteries of soy
Should you try soy for menopausal symptoms?
Soy isn’t for everyone and as the comments from Monday’s post show, it may be downright dangerous for some populations. However, my goal is to present you with invaluable information about options for addressing troublesome menopausal symptoms — information that isn’t always readily available or accessible, — which is why posts about the evidence for potential benefits (and risks) of soy are so important.
That’s why I’m reaching out to you today. I want you to help me help you burst the mysteries and controversy surrounding the use of soy isoflavones for menopausal symptoms like hot flashes or mood swings.
Here’s how:
The University of Illinois at Chicago Center for Women’s Health is looking for healthy, perimenopausal women between the ages of 40 and 55 to take part in a research study. Sponsored by the National Institutes of Health, The R.I.S.E. (Research Investigation of Soy and Estrogen) study will compare a soy tablet (Novasoy® ) to estrogen and placebo in order to evaluate the effect on hot flashes and other menopausal symptoms. You can learn about the specifics of the study at the RISE website.
Why it’s important to spread the word.
We will never know if phytoestrogens like soy, and other alternative therapies are truly effective without having ample evidence to back claims. Many Western practitioners, including former editor of the Journal of the American Medical Association, George Lundberg (who recently wrote that “there is no alternative medicine, only unproven medicine”) continue to argue against inclusion of alternatives in our medical system. My mandate and promise to you has always been to provide you with sound strategies that will empower you to make the best decision about your physical and mental health and wellbeing. Navigating the midlife transition — whether it’s menopause, general health issues, career changes or relationships isn’t easy — but it can be less challenging with the proper tools and roadmap to make decisions that work best for you.
We will never be able to take control of our journey without fully engaging in the process. Not only does this include educating ourselves but also taking responsibility for the changes we wish to see.
Let’s face it; participating in a research study isn’t everyone’s cup of tea. However, the University of Chicago needs your support and so do I.
Let’s rise to the occasion shall we? Won’t you help spread the word?
Read MoreSoy! Everything you wanted to know. Or should.
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:
- low-dose hormone therapy (a Activelle ®tablet daily, better known as Activella® in the US) plus a placebo powder or
- 2 portions daily of dietary soy supplementation powder (comprising 45 mg isoflavone per dose) plus a placebo tablet, or
- 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.]
Read MoreHot Flash Havoc: fear and loathing in the menopause
Author Louise Foxcroft, writing in Hot Flushes, Cold Science, points out that “fear of the menopause is something we have learned, and it has grown out of a general, male and medical distaste for the idea of the menopause perceived as an end to viability, fertility, beauty, desirability and worth. Since the French physician de Gardanne coined the new term ‘ménépausie’ in the early nineteenth century, an onslaught of opinion, etiology, treatments, and not least and lest we forget, profit has followed. Women need to unlearn their dread and recognize that menopause is not, of itself, dread-full; that we are merely the victims of our biological process.”
We have also been victims of the fact that menopause has been “thoroughly medicalized in Western Culture.” The result?
Our bias is to think of menopause as a disease, something that needs to be fixed, treated and eliminated. The solution is inevitably hormone replacement therapy or HRT.
Supporters of HRT will fight tooth and nail against evidence from the Women’s Health Initiative Study that showed that the risks associated with hormone therapy may outweigh the benefits. Their argument lies with the contention that the findings relate to women who were on average, 63 years of age, considerably older than the average age that women start menopause, and that the data are not applicable to younger women. Moreover, had these very women been given hormones earlier, they would have had protection against a multitude of diseases, including heart disease and osteoporosis. Critics of HRT, on the other hand, point to data showing that length of time on hormones, timing of hormones and genetic disposition can increase or decrease a woman’s risk for disease, that HRT doesn’t protect against heart disease or stroke and may in fact, significantly increase disease risk, in particular, breast and ovarian cancer, and death from lung cancer.
Last weekend, I sat through Hot Flash Havoc with a group of female friends. Together, we range in age from 47 to 57. Two of us have had multiple bouts of cancer while three of us have lost loved ones as a result of cancer. Our mothers have had hysterectomies, mastectomies, hot flashes or no flashes. Some are still alive and others have passed. In composite, we are representative of the modern woman: savvy healthcare consumers, avid data hounds, curious, communicative and sometimes outspoken. As one of my friends stated, we are “rolling into a new phase” or have already rolled into it: menopause.
I couldn’t think of a better, more objective way to screen Hot Flash Havoc, “the most provocative and revealing film ever made about menopause.”
Provocative? You bet!
Revealing? Yes!!!!! But not in the way that the director, producers, writers or underwriters intended. Rather than debunk myths about menopause, they have produced a documercial that the women in the room described as:
“Condescending.” “Patronizing.” “Not very well done.” “One-sided.” “Unhelpful.”
And my favorite: “a giant estrogen dildo.”
Hot Flash Havoc promises to “set the record straight about the Women’s Health Initiative study released in 2002, which misrepresented that the hormonal replacement therapy being used by millions of women to treat the symptoms of menopause could actually increase the risk of heart attacks and cancer” and further, “shed insightful light on the confusion stemming from a decade of misguided facts [through] poignant personal stories shared by real women and in-depth interviews with the world’s most noted experts.”
However, the reality is somewhat different. This film of “menopausal proportions” is a meandering, sometimes cartooned montage of HRT hype and bias. Attempts to turn ‘women’s anatomy 101’ into humorous animations of talking vaginas, vulvas and ovaries begs the question: have we somehow stumbled onto a grade school class on menstruation? (By the way, the only thing missing were the tampons and sanitary napkins, which of course, would have no place in the menopause medical cabinet. )
Along with a dash of failed humour is the film’s dose of intrigue, not about the mysteries of a woman’s body but rather surrounding accusations of a government conspiracy underfoot to undermine decades of evidence supporting the use of HRT. Indeed,the National Institutes of Health, which halted the hormone arm of the Women’s Health Initiative study is blatantly accused of attempting to rob women of HRT in a selfish quest fueled by self-promotion.
Wait! The government is conspiring against women who need their hormones???!
The circus-like atmosphere of Hot Flash Havoc is beautifully orchestrated by pro-HRT doctors disputing evidence, ‘enlightened experts,’ and of course, a bevvy of Botoxed babes who went through terrible withdrawal when their doctors made them stop taking their HRT. The message? Women: you’ve been duped!
Hot Flash Havoc misses the mark because it robs the viewer of any objectivity or information about how women and practitioners in different cultures and countries address menopause. Moreover, with the exception of a token naturopath thrown in for good measure, alternative strategies are portrayed as ineffective shams and their proponents, as greedy blood suckers who care more about profit than the women they serve.
One of my friends asked if the film’s intention was to provide enough information to make an informed decision. If so, she said, it fails terribly. Another friend commented that the film portrays menopause as an illness and said that she thought that the film’s underlying message is that menopause is not natural and needs to be cured, that there’s something wrong with you.; ‘it makes me angry,” she said. The overriding complaint was the clincher: this film is really about instilling a fear of aging and illness and the need for a remedy, a ‘miracle’ drug: estrogen.
Hot Flash Havoc is an infomercial of menopausal proportions, a messy mash-up of HRT hype and fear and loathing, a big estrogen dildo just waiting for an opening. Do yourself a favor: don’t let it wreak havoc on your psyche. This one’s a dud.
A huge thank you and love to my Roller girls and partners in crime — Turn A Head, Wendy Wildstar, Biker Babe and Red — for their comments and insight. Couldn’t have written this one without you!
p.s. Bob Dylan wants his album cover back.
Wednesday Bubble: Time to debunk the hype about traditional Chinese Medicine
This week is dedicated to the debunk – debunking the absolute need for anti-anxiety medications (it may be your flashes, not your mood), debunking the myth underlying the lack of published data supporting the use of traditional Chinese Medicine (TCM, e.g. acupuncture and herbal medicine) and debunking the one-sided, endless loop about hormone replacement therapy.
Because Wednesday falls in the middle of the week, I want to focus on traditional Chinese medicine, which is considered part of the offerings that fall under the umbrella of “complimentary and alternative medicine.” As a practice, TCM was created roughly two thousand years ago and refined in the centuries that followed. And yet, Western practitioners continue to question its value because they claim that there is no real evidence supporting its therapeutic effectiveness. No evidence? A quick search on Google yields countless databases, with one example housing over 400,000 studies and abstracts, many of which have been published in reputable Chinese biomedical journals over the past several decades.
The challenge and the solution
Unquestionably, the evidence doesn’t look quite as strong when strict Western methodology is applied to Eastern philosophies without addressing their distinctions. In fact, a prime example of what happens when the paradigm shifts is the ACUFLASH study, which as I reported earlier this year and late last, demonstrated the benefits of acupuncture when the investigator practitioners were allowed to incorporate some invidualized therapy into the mix.
So what exactly does that mean – to incorporate individualized therapy into the mix?
A unique aspect of the ACUFLASH study was the ability of the practitioners to work within a defined framework but with the addition of directing therapy to each participant’s specific needs. In other words, the practitioners met before treatment and agreed on the specific symptoms or conditions they would include in the study as well as the specific acupuncture treatment points they could work on. This organized system meets some of the strict criteria of Western scientific study. However, they could then choose which of the the treatment points would most benefit a given participant’s system imbalance as well as provide possible diagnoses and self care recommendations (e.g. soy, herbs, physical activity and relaxation techniques) which participants were free to add at their own discretion. This ability to work within the confines of both Western and Eastern practice resulted in significantly beneficial results.
TCM versus Western Medicine
TCM and other similar philosophies emphasizes various body systems that together, form a network or grid connected by a meridien, if you will, as well as the relationship of the body to its social and natural environment. Its primary focus on maintaining health and enhancing the body’s ability to fight off disease. TCM will not focus, for example, on treating specific pathogens but rather, on addressing non-specific factors that create disturbances or imbalances within a certain network. TCM also examines how these imbalances may occur in unique parts of a specific system, such as the heart and blood vessels and small intestine (all of which are part of the heart system) and how they change over time. Western medicine, on the other hand, focuses primarily on treating morbidities, or symptoms related to various conditions and diseases.
Another point of distinction is that while Western practice is geared towards treating specific causes and symptoms of a disease, it doesn’t do so well when the causes or influences are less specific or more importantly varied. Sexual desire, or lack thereof, is a perfect example. It’s been demonstrated time and again that certain aspects of menopause or aging, for example, sexual desire, are not only related to physiology but also to environmental factors. And while the addition of estrogen can certainly help to keep vaginal juices flowing, so to speak, it can’t address social, psychological or behavioral factors that might also be influencing that desire.
I have said it before and I’ll say it again: my dream will be fulfilled when East meets West. I’d like to see greater integration of of the two philosophies and less push back from the Western Medical Establishment against TCM. Calling it a ‘sham,’ because it doesn’t fit into the traditional mold, calling it snake medicine because it isn’t based on medical school learnings, and refusing to examine published scientific papers that have been translated, however roughly, into English, does a disservice to the patients who might benefit from the integration of the two.
Since when are hot flashes and mood swings ‘pathologies,’ symptoms of a disease that requires drug treatment?
Isn’t it time to separate fact from fiction, hype from hope and myth from truth. TCM isn’t a sham. And menopause? It can truly be addressed without drug therapy.
Read MoreFeeling anxious? It may be those hot flashes!
Researchers say that there may be a link between hot flashes and certain types of anxiety. In fact, hot flash symptoms — increased heart rate and feeling flushed — have been shown to mimic feelings associated with somatic anxiety, i.e. butterflies in the stomach and tension (as opposed to affective anxiety, which people feel panicked or afraid or nervous).
Importantly, data have shown that as much as 8 months before premenopausal women start experiencing or reporting hot flashes, their scores on an anxiety index are off the charts, which means that constant butterflies or tension may be predictive of the move into menopause. The reason this is important is that they may be steps you can take now to address symptoms as they start to emerge, yoga and deep breathing for example, which not surprisingly, are often recommended to address anxiety symptoms.
The latest bit of information to hit research circles involves a study of 80, healthy, well-functioning menopausal women who were asked to keep a daily diary on hot flashes or night sweats (defined as a feeling of warmth or heat accompanied by sweating, pressure or rapid heartbeat occurring while awake or during sleep). In the diary, participants were asked to record how often hot flashes occurred over a one-week period as well as their severity. They were also asked to rate any symptoms of anxiety based on how often they occurred.
The results?
Higher scores of anxiety related to tension and butterfly-like feelings but not to panic or nervousness were significantly associated with more severe and frequent hot flashes or night sweats, even when factors such as sleep quality, age and education levels, all which might affect anxiety levels, were factored in. Age in particular is important because hot flashes tend to wean through the menopause as women grown older.
The reason this preliminary research is important is that it is possible that anxiety that women experience during menopause is actually related to hot flashes, rather than a specific mood disorder. By shifting the viewpoint to the true culprit, healthcare practitioners and women alike, might be able to better diagnose and more appropriately address anxiety symptoms, rather than leaning towards prescription mood treatments that are uncalled for.
At the same time, more research is needed. This was a small group of healthy, white women who were asked to self-report hot flashes/night sweats and anxiety symptoms. Although most of the research on hot flashes does rely on self-report, objectivity can be lost. What’s more, because these women were psychologically healthy, it’s hard to apply any conclusions to older women who might be seeking assistance specifically for anxiety.
So, are you feeling anxious? Depending on your age and menopausal status, it might be a harbinger of the flash or due to the flash. Either way, it’s worth considering.
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