Search results for isoflavones

Iso what? Iso who? Hot flashes, isoflavones and clinical trials

Posted by Liz on Mar 25, 2013 in hot flash | 0 comments

I’ve long been intrigued by the replacement of hormone replacement therapy with soy isoflavones. Yet, studies looking at their effectiveness for alleviating hot flashes and other vasomotor symptoms have been mixed. The reasons for this are multiple, and point to such factors as dose and actual composition of the supplements used, severity of hot flashes and how often women are taking isoflavones over the course of the day. Researchers have also discovered that only 20% to 30% of Westerners produce equol, (there’s even a dispute over this stat) a component of the potent isoflavone dadzein that has an affinity for estrogen and appears to be slowly cleared from the body;(note that both of these factors contribute to its beneficial effect against flashes.

Despite these challenges, what would happen is you simply upped the dose and/or frequency? Would it change the’ iso what’ or ‘who’ to an actual ‘iso yes!?’

That’s exactly what researchers sought to learn when they recruited 130 peri- and post-menopausal women with severe hot flashes (i.e. five or more  a day). Women who produced equol and those who did not were separated and then randomly asked to take placebo, low dose (33 to 66 mg/day) or high dose (110-200 mg/day) equol or placebo capsule (s) and take them once daily or two to three times daily. They also kept daily hot flash diaries, assessing each hot flash by its intensity, daytime or nighttime occurrence and how bothersome they were. They met with the research team face to face twice — 9 weeks in, and 3 weeks after the study completed.

The findings made it quite clear that dose and frequency are almost as important as whether or not a person is able to produce equol. In fact, when women took higher doses of isoflavones more frequently, they had 2.4 per day fewer hot flashes than women taking the lower doses just once a day. And, the flashes were significantly less severe. What’s more, most of these benefits were realized during the night, when, as most of us know, flashes and sweats are especially disruptive. Moreover, there was not much of a difference between women who are able to produce equol and those who are not; while these women did experience greater declines (as much as 10%) in both how intense their flashes were and how frequently they occurred, the difference was apparently not statistically significant.

So, let’s cut through the scientific clutter:

• Higher doses of isoflavones tend to have a greater effect than lower doses
• More frequent dosing (two to three times a day) appears to be more beneficial than once a day dosing.
• Greater benefits are likely to be seen in women who naturally produce equol, especially when it comes to hot flash intensity
• Both perimenopausal and menopausal women may potentially benefit from higher, more frequent dosing.

This type of research is just beginning and the findings need to be teased out in larger numbers of women. It’s also unclear if spreading the lower dose out throughout the day would make a difference. Still, what these findings do bring to light is an evolution of thinking and that’s what makes me most excited. Rather than determining that isoflavones are useless, researchers are finally starting to treat them as though they were pharmaceutical agents, using them in randomized clinical trials, varying doses, frequency and patient populations and truly, thinking outside the box.

Dem bones! Isoflavones, S-equol and aging

Posted by Liz on Feb 7, 2011 in bone health | 1 comment

I love it when readers of this blog point me to research that I might have missed or just not stumbled across. That happened a few weeks ago after I wrote a post on soy and safety. By following the links, reader Carol Land directed me to a newly published study on S-equol and bone health.

S-equol is a metabolite of a major soy isoflavone called daidzein. It has a particular affinity for estrogen receptors and possesses some estrogen-type activity of its own. S-equol  is produced in the gastrointestinal tract however the ability to actually manufacture it depends on the presence of certain microflora. Consequently, only 30% to 60% of individuals are actually able to produce S-equol on their own (although this figure is believed to be higher among Asians and vegetarians).

The surge in interest in S-equol is related to its potential for augmenting the benefits of isoflavones; in fact, it is possible that women who are naturally producers of S-equol actually experience greater effects from soy products, and this is especially true when it comes to bone health.

I cannot stress enough the importance of bone health as we age. Declining levels of estrogen are a primary cause of bone loss and resulting osteoporosis in women; indeed, one in five American women over the age of 50 have osteoporosis and about half will experience a fracture in the hip, wrist or spine as a result. What’s more, because osteoporosis is silent in its early stages, causing no symptoms, it’s critical that bone loss is halted or at least slowed either before or during the most critical phases strike. There is no time like the present to take preventive measures, even if you are in your 30s and 40s.

Where does S-equol fit in?

For the first time, researchers have shown the daily S-equol supplements taken by women who are not naturally producers of S-equol, may improve bone metabolism and attenuate bone loss!

In this 1 year study of 356 healthy, postmenopausal Japanese women between the ages of 41 and 62, daily intake of 10 mg S-equol via supplement markedly reduced markers of bone resorption in blood and urine compared to women taking placebo pills or 2 mg or 6 mg of S-equol daily. In fact, in women taking the 10 mg dose for a year, declines in a  urinary marker of bone resorption (i.e. DPD) were roughly 21% greater compared to placebo. Measures of whole body bone mineral density also showed that S-equol supplementation protected against bone loss, although not to the extent as bone resorption. These results remained even after changes in height, weight, body mass index, lean and fat mass were accounted for. No participant experienced serious side effects from taking S-equol and hormone levels were not adversely affected.

Does this mean that you should rush out and purchase S-equol supplements?

One of the primary limitations of this study is that the process of bone recycling can take as long as 18 months and the time required to complete a cycle may actually increase with age. Thus, the duration of time that the women were studied might be too short to draw any definitive conclusions. Hence,  you may want to wait before you start taking S-equol. However, the evidence that’s building continues to put the weight on the benefits versus risks side. Only time will tell. Meanwhile – here’s to your bone health. Keep on doing all you can do to keep dem bones.

Newsflash: What’s the latest on soy?

Posted by Liz on Oct 17, 2014 in hot flash | 0 comments

Does it or doesn’t it? That is, does soy  relieve menopausal hot flashes or not?

The evidence has been less than definitive however, researchers now say that trials examining the benefits or lack thereof of soy in attenuating symptoms may have been negatively affected by significant limitations, such as failing to recognize treatment timing and duration on effectiveness, small numbers of women in the studies and wide variations in how much hot flashes were reduced with treatment. And so, they took another look at the data using a new model, one that allows scientists to actually compare different treatments and evaluate the effectiveness of different factors, including dose, duration of treatment and formulations. This is an important method of analysis and one that could truly be considered a game changer. They say that their findings, published online in the British Journal of Pharmacology, will provide “information for deeper understanding of the efficacy of soy isoflavones on menopausal hot flashes.”

I am going to skip over the science mumbo jumbo and get right to the meat of how they came to their ultimately conclusions:

• Findings were based on an analysis if 16 studies published between 1998 and 2012 enrolling over 1700 subjects.
• In terms of duration, the effect of soy isoflavones were studied for anywhere from 4 weeks to two years, with a median of 12 weeks.
• In these studies and vis a vis modeling, soy isoflavones were compared to both placebo and estradiol, the latter in terms of how long it takes to reach effectiveness. This last point is important.

And now, the result.

While the effect of isoflavones on hot flashes was superior to placebo, the researchers still observed a relatively strong placebo effect at play. Importantly, however, the placebo effect at play was even higher in trials examining estradiol and hot flashes. The reason? Apparently, women might have lower expectations when it comes to alternative therapies like soy. Yet, there was still another important finding that was teased out by this new modeling:

Soy isoflavones require at least 13.4 weeks to reach at least half of their  full level of activity in the body. In comparison, estradiol only needs about 4 weeks. So, when you do the math, at four weeks (which is the usual length of most clinical trials of this nature), estradiol has reached 80% of its peak activity level and soy isoflavones, only 47%. By 48 weeks, soy isoflavones catch up.

Additionally, as I’ve written time and again, there are different components of soy with differing levels of effectiveness. Genestein is the strongest and yet, only three studies specifically looked at soy agents that contained genestein only. So, there was no way for the researchers to break down the findings by components.

Overall, the key takeaway is that it takes longer for soy to reach maximum effectiveness than it does estrogen. So, if we are going to quantify value moving forward, it’s important to account for this significant distinction.

When it comes to soy, it may simply be that slow and steady wins the race.

Newsflash: Ethnic, flashing and menstruating. Three’s a charm?

Posted by Liz on Aug 26, 2013 in hot flash, nightsweats | 0 comments

Sounds too awful to be true. However, a study of an ethnically diverse group of women has shown that having regular periods, which, theoretically indicates that hormone levels are more on par than their menopausal sisters, may not be all that they are cracked up to be. In fact, among approximately 1,500 women (mean age 48.5), 54% reported having had either hot flashes (~33%) or night sweats (~46%) at some point and recently, anywhere from 17% (hot flashes) to 26% (night sweats). Moreover, it appeared that Black and Native American women were most vulnerable, while Asian women were the least. The numbers among white women were only slightly lower than their Native and Black peers.

What’s so interesting about these data is that typically, obesity has been associated with a self-reported increase in vasomotor symptoms among menopausal women. However, in this group of women, the researchers deliberately adjusted their findings for BMI and age, and they did not find that association. In fact, when they looked at Hawaiian/Pacific Islander women, who had, on average, the highest BMI of all the ethnic groups studies, only 45% reported ever having a hot flash or night sweat, compared to 58% of white women (who had some of the lowest BMIs amongst the group).

Why it matters…

Many women operate under the assumption that it won’t happen to them. Cancer won’t happen. Losing a spouse won’t happen. Having a hot flash or night sweat while still menstruating won’t happen. I refer to that as the ‘teenage mindset,’ since we all know that teenagers are among the most prone to the ‘won’t happen to me’ syndrome. And yet, the data suggest otherwise; even before menopause starts, a hot flash can occur. And it can be bothersome; of the entire group of women who said that they had had some sort of vasomotor event in the prior two weeks, anywhere from 38% (Asian women) to 80% (Hawaiian/Pacific Islander, Native Americans) said it was at least moderately bothersome. White and Black women fell in the middle.

I cannot emphasize it enough; early action is the best action. Don’t wait until you are in the throes of menopause; start now to boost your preventive strategies, whether they entail isoflavones, hypnosis, yoga or acupuncture. I am all for curtailing the worst wherever possible; shouldn’t you be?!

Wednesday Bubble: Lub(e)-a dub dub

Posted by Liz on Jan 23, 2013 in vaginal atrophy | 6 comments

Vaginal atrophy — thinning and drying of the vaginal tissues as a result of declining estrogen levels– leads to itching, burning, dryness, irritation and pain. And while it certainly isn’t the silent scourge overtaking women globally, it does affect roughly 50% of menopausal women and often goes unrecognized and undiagnosed. More importantly, unlike hot flashes and night sweats, vaginal atrophy does not go away; rather, in some women, may may progress to cause years of discomfort, so much so that quality of life is significantly impacted. Indeed, data suggest that the proportion of women experiencing vaginal dryness increases five-fold as women advance through menopause.

Importantly, results of a recent global survey indicate that most women choose over-the-counter lubricants and are not even aware that a low-dose, relatively safe topical estrogen treatment is available. Still, for many, over-the-counter options are enough, such as Replens, which theoretically goes beyond instant relief and actually provides ongoing protection. However, what should you do if sexual intimacy continues to be uncomfortable, your vagina feels increasingly uncomfortable and hormones are an undesirable choice?

Isoflavones baby!

Yup, soon, you may be able to leave the over the counter and hormone therapy options behind for a safer, effective treatment. Reporting in the online version of Maturitas, researchers state that they have been exploring plant-like estrogens in a topical gel format can deliver benefits similar to topical estrogen gel without p0tential safety issues. And, when they blindly compared 12 weeks of a 1 gm isoflavone gel to topical Premarin or placebo gel in 90 menopausal women, that’s exactly what they found!

At the beginning of the study, 100% of women reported vaginal dryness and pain, 82% said that they had itching and 72% complained of vaginal discharge. In women receiving the isoflavone gel, as many as 70% reported that their dryness was intense and 60% said that their pain was intense. By the end of 12 weeks, improvements were seen in both vaginal dryness and vaginal pain; no women reported having intense symptoms and roughly half said that their symptoms were mild. Overall, roughly 97% of women using isoflavone gel saw improvements in both vaginal dryness and pain. Similar figures were observed in women using topical estrogen.

Now here’s the science geeky part. When the researchers took a closer look at the cells in the vaginal wall, they noted a shift towards values that one would see in a premenopausal woman. And, whereas topical vaginal hormone therapy sometimes results in vaginal bleeding and thickening of the lining of the uterus, these issues were not seen in women using the isoflavone gel (neither were they noted in women using topical estrogen, probably due to the extremely low dosage).

The researchers say that it appears that the isoflavone gel can be used safely without any risk of systemic absorption. Now? We need more studies so we can get this gel to market.