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 MoreWednesday Bubble: the soy controversy
Do they or don’t they?
Soy isoflavones have been touted as beneficial in everything from improving body composition and lowering breast and colorectal cancer, to addressing menopausal hot flashes and moods. You can read about some of these findings on Flashfree. This week, Reuters Health reported that eating foods rich in soy protein (i.e. 25 grams of soy protein and 60 mg isoflavones) daily did not provide favorable responses from blood fats, implying that soy has little benefit in terms of lowering cholesterol levels and in turn, promoting heart health.
Are you confused yet?
Increasingly, women are turning to soy and other compounds as alternatives to estrogen and hormone replacement therapy, which mounting evidence shows can be associated with a broad range of risks including increased breast, lung and ovarian cancer to heart disease. And yet, findings from clinical trials examining soy are often contradictory, making it difficult to come to any firm conclusion about its benefits.
What’s the problem? Well, researchers say that part of the problem is poorly designed studies, small number of study participants, wide range of ages and years from menopause, studies that don’t examine the pros and cons of an agent or strategy for a long enough period of time (i.e. longer than a year). In other cases (as I’ve argued previously), the study design does not account for certain factors that are critical to a therapeutic strategy, for example, the opportunity to clearly focus an intervention so that individual factors are accounted for (this was borne out by findings from a trial that examined and provided evidence for the role of acupuncture in easing hot flashes).
There’s good news though! Researchers finally appear to be getting their act together on the soy fron. They’ve announced that they are conducting a well-designed, large trial of soy phytoestrogens. Called SPARE (Soy Phytoestrogens as Replacement Estrogen), this new study will be looking at the effects of 200 mg soy versus sugar tablet daily — namely on bone health and symptoms — in 248 menopausal women over a two- year period. They will also be taking daily calcium carbonate plus vitamin D (in ranges of 500 mg to 1000 mg calcium and 200 to 400 IU vitamin D, depending on previous intake).
The study is specifically geared towards looking at spine bone density, but will also be looking at hip density, thyroid levels, menopausal symptoms, mood changes, depression, and quality of life, as well as any changes in blood fats. Study participants are between the ages of 45 and 60 and are within five years from menopause. What’s more, the researchers have also included a large percentage of hispanic women, which allows them to focus on how soy affects this minority group (Notably, the large multiethnic population of women in this study includes Asians, Blacks and Caucasians.)
The researchers say that they hope that the results of SPARE will provide a range of information that is especially relevant to Boomers reaching menopause. They also note that the dose of soy isoflavones being studied is much larger than what’s been studied in previously and are roughly twice that typically consumed in the Asian diet.
I realize that this post is pretty scientific. But what makes it most relevant is that it appears that researchers are finally starting to design studies that might actually show benefit of some of the alternative strategies we have available to us on the market. For those of you who insist on calling these alternatives “snake oil,” all I can say is ‘stay tuned.’
This bubble might finally be shattered; perhaps all that is needed is a better understanding of what it needs to test these substances appropriately.
Read MoreGot fat? Soyrry but soy won’t help!
Novel research suggests that eating soy protein won’t affect overall body composition, even though there has been some past evidence that isoflavones in soy may help build muscle mass and break down fat. What’s the 4-11?
In this latest bit of data, 299 postmenopausal women with body-mass indices of around 25 (signifying “overweight”) too either placebo or soy isoflavone tablets for a year. The findings? Ingesting soy isoflavones had no significant effect on either body composition or on specific hormones that control appetite. The one factor that contributed to fat mass? The amount of total fat consumed.
Seems that the way to a more muscle mass is not through soy but rather, through a healthy diet and of course, exercise. Still, can we women ‘of a certain age’ get rid of the tire that’s forming around our middle? I’d love to hear how if you’ve got some ideas. Even my trainer admits that hormonal changes add to the roll and that it’s difficult to get rid of it completely.
Fortunately, the folks at Rush University Medical Center will be studying this midlife dilemma over the next five years. While they say that there’s no way to completely eliminate the tire, there are ways to minimize it. Stay tuned!
Read MoreMore joys of soy
More news on soy. Researchers have discovered yet another component of soy isoflavones that may prove useful in improving symptoms of menopause: soy aglycons of isoflavones (SAI). Soy aglycons are a group of chemicals found in fermented soybeans and comprise a great portion of diets for Chinese and Japanese individuals. Of note, high cholesterol, coronary heart disease, and menopausal symptoms are often seen in a smaller percentage of these women than their European and American counterparts.
Among the various chemical molecules of soy, SAI are absorbed faster and more efficiently than other components.
In this particular study, which was just published in Nutrition & Metabolism, researchers fed rats whose ovaries had been removed either high or low doses of SAI-supplemented diets. These animals were then compared to rats with intact ovaries who were fed a regular diet.
The researchers found that rats fed supplemental SAI had significantly lower cholesterol and low-density lipoprotein (LDL) values , higher high-density lipoprotein (HDL) levels and faster liver metabolism. The lining of the uterus was also enhanced by dietary SAI supplementation.
They said that these results suggest that SAI may help protect against or lessen symptoms during menopause that are associated with the natural decline of estrogen. SAI might also be an effective and safe alternative to HRT, which has been linked to breast and uterine cancers. In general, SAI may protect against menopausal heart disease.
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