There’s a new kid in town: Menerba®. Although it’s not yet available, the Food & Drug Administration has cleared the way for its manufacturing and production.
Menerba is characterized as an oral botanical drug because its activities are derived from botanical sources, implying that although it is is a pharmaceutical agent, it acts like a plant-based formulation. Nevertheless, Menerba, which is a selective estrogen receptor modulator (or SERM) is apparently a safe alternative to both selective and non-selective SERMS, as well as HRT, for the treatment of hot flashes/vasomotor symptoms associated with menopause. The reason it is considered an alternative is that unlike traditional SERMS, which activate estrogen pathways that have been implicated in breast and uterine cancers, Menerba specifically targets the estrogen pathway in the body that is directly associated with hot flashes. So, theoretically it should be equally if not more effective for addressing hot flashes and also, safer than agents that have come before it.
Thus far, Menerba has been shown in clinical studies to reduce hot flash frequency by as much as 50% and also significantly improve sleep disruptions due to night sweats, with higher doses yielding the best results. Generally, it is well tolerated and has not had any noted impact on uterine or breast tissue. A larger trial of 600 postmenopausal women is slated to begin this year and is currently recruiting.
The bottom line?
Menerba looks pretty promising. I’m not quite sold on the characterization of Menerba as a botanical and would like to see more information on this, especially because its characterization as such could certainly be confusing once clinical trials are completed and the drug reaches the market. Nevertheless, you may want to keep an eye out for this new kid in town.Read More
Crowdsource has become the buzzword of the oughts and the interwebz. Defined as leveraging mass collaboration in order to achieve a common goal, it’s not unusual to find businesses crowdsourcing charity efforts, authors crowdsourcing written works and musicians crowdsourcing performance pieces. However, can healthcare be crowdsourced?
I believe it can, as witnessed by the burgeoning epatient movement (aka participatory medicine). In fact, this week, I’m taking a break from my regular schedule to attend ePatient 2010 in hopes of gaining a better understanding how participatory medicine, collaboration between consumers of healthcare and their practitioners and empowered patients will drive the cultural shift that is taking place within our healthcare system.
More importantly, however, is the fact that I believe that as women, being empowered, i.e. educating ourselves, asking hard questions and participating in decisions in our healthcare, is the only way that we can truly take back our transition to midlife and menopause and remove the decisions about managing it from the hands of industry and practitioners who insist on medicalizing it.
So, where does crowdsourcing fit in?
Last week, I wrote a post about Hot Flash Havoc, the documercial that’s about to be screened in Washington DC and other cities this week. In the process of writing about the film, I realized that the director and producer had unwittingly crowdsourced their piece by asking a lot of pro-HRT experts and patients to join forces to promote so-called discrepancies in the Women’s Health Initiative Study and the foibles of the National Institutes of Health. In the case of this particular project, crowdsourcing actually did a disservice to the multitudes of women who remain confused and lack guidance about HRT and its risks and benefits.
Simultaneously, however, screening Hot Flash Havoc for a group of women provided a glimpse into how menopause could be crowdsourced in more positive and empowering ways. In fact, once we moved on to the broader topic of menopause, the post-film discussion focused on our lives, our personal challenges with menopausal symptoms and most importantly, strategies for dealing with them. Not surprisingly, this conversation continued a week later, when a smaller group got together for drinks and dinner and once again, started discussing the film in general and dealing with menopause specifically.
Women are strange creatures. They often share the most intimate of details with strangers but they can be embarrassed to discuss health concerns with their close friends. Two women can find a bond instantly with little forethought or effort and yet, that bond can be a barrier when things get too personal, or as one friend put it, “embarrassing.”
Why do we continue to be embarrassed to discuss menstruation, hot flashes, night sweats, mood swings and headaches or joint pain? Since when did it become taboo to find ways to utilize our common grounds for a larger cause?
So, this is what I’d like to propose:
Let’s start talking…to each other, to our practitioners and to the world. Let’s figure out what we need, research the hell out of it, seek second and third opinions and insist on making decisions with our practitioners rather than going along with decisions without questioning them, especially when they feel wrong. Let’s take back menopause and midlife and the transition and make it an acceptable and natural part of aging. Let’s stop making and treating it as a disease and put an end to self-loathing and stigmatization.
Let’s crowdsource menopause in a positive, proactive way.
You in?Read More
I have a friend on Twitter who coined the phrase “can’t remember shit.” This phrase greets me throughout the day because I am constantly forgetting even the simplest things. Why did I enter this room? What was I going to look up? How did I get here? Why can’t I focus? And lists? Fuggedaboutit – they don’t do squat; even when I have them, I forget.
I blame my memory and focus problems on hormones all the time. However, if this were true, then the addition of hormones, in particular estrogen, would balance out the forgetting and boost my attention and focus, right?
Hence, I was intrigued when I ran across a small study in Menopause looking at cognition and stress, which seemed to back an earlier contention that stress plays a huge part in recall ability in menopausal women.
In this rather small trial, 22 postmenopausal women (50 to 83 years) took either placebo or an estrogen tablet (1 mg estradiol daily for one month and then 2 mg daily for two months). After three months, they were asked to ingest a substance that depleted certain compounds (called monoamines) that the body manufactures and uses to stabilize mood, perform a mildly stressful test, and then undergo a series of tests on stress levels, mood, anxiety and cognition.
It appears that at least in this small group of women, taken estrogen was actually linked with poorer cognition following a stressful event, including the ability to recall words and slower reaction time. Because this occurred independently of the depletion of mood compounds or negative mood, the researchers say that the effect of estrogen, which has been shown in some studies to improve cognition, is not as straightforward as previously believed. What’s more, the significant increase in stress and stress reactions during menopause may actually interfere with estrogen benefits in so far as memory and recall go.
Our lives are increasingly busier, especially now that we can be connected 24/7. Personally, I can’t even get a work out into my day without some sort of interruption. That’s why it’s so important to figure out how hormones interact with stress, so that we can make informed decisions — not only about menopausal decisions — but also about general life decisions.
Look, memory recall and attention are undoubtedly linked to aging, at least to some extent. But now? Stress may be playing a role in how hormones impact our reactions, focus and attention span, and memory. So the next time you can’t remember shit? Maybe a few deep breaths can help.
No wonder!Read More
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.
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 More
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?
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.
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 More