Blog of the Society for Menstrual Cycle Research

Brisdelle for Hot Flashes

October 14th, 2013 by Paula Derry

The North American Menopause Society held its annual meeting Oct. 9 to 12. An article posted a few days earlier stated that hot flashes would be “extensively discussed” at the meeting because “temperature control is such a preoccupation for menopause.” There would be 13 presentations on low-dose paroxetine mesylate (brand name Brisdelle), “the first nonhormonal treatment for hot flashes to be approved by the US Food and Drug Administration.” A link was provided to an article about the FDA approval.

The article is titled “Brisdelle okayed as first nonhormonal Rx for hot flashes.”  However, the content of the article states: “The first nonhormonal drug for hot flashes associated with menopause was approved by the US Food and Drug Administration (FDA) today despite an agency advisory committee having rejected it as too much risk for minimal benefit. …The FDA’s Advisory Committee for Reproductive Health Drugs voted 10 to 4 against recommending approval. …The FDA is not obliged to follow the advice of its advisory committees, but …it usually does.” 

With regard to risks, the same article states: “Critics said the drug’s minimal superiority to a placebo did not outweigh the risk for suicide ideation and osteoporosis, 2 adverse events associated with paroxetine. …The drug’s label features a boxed warning about the increased risk for suicidality. The label also warns clinicians that paroxetine mesylate can reduce the effectiveness of the breast cancer drug tamoxifen if taken together, increase the risk for bleeding, and comes with the risk for serotonin syndrome.” 

Risks might be worth it if they are unlikely and there is a large benefit. In testing paroxetine did better than placebo, so it was accurate to state that the medication had an effect. However, the absolute advantage of the medication compared to placebo was small. For example, at week 4 of the study, 60% of the women taking the medication reported relief but so did 48% of the women taking a placebo; at 12 weeks, 47.5% vs. 36.3%.

Some clinicians with patients with severe hot flashes, and some women themselves, have had the experience that serotonin reuptake inhibitors (the class of drugs that includes Brisdelle) have worked. The article on the FDA approval speculates on why the medication was approved: “In a news release, the agency seemed to explain why it overrode the recommendation of its advisory committee when it came to paroxetine mesylate. ‘There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,’ said Hylton Joffe, MD, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.”

For women with severe hot flashes, an effective treatment is needed. Yet, surely, a treatment with potential side effects should pass a high bar before being FDA approved.

A Review of Selene: A New Cycle-Tracking App

September 2nd, 2013 by Chris Bobel

Guest Post by Amy Sedgwick, HRHP, Red Tent Sisters

Screenshot of Selene app // Photo courtesy of daringplan.com/selene

While there are no shortage of apps designed to help women track their periods, finding an app that meets the needs of women who are practicing fertility awareness methods (FAM) for birth control or conception can be quite a challenge. As a teacher of the Justisse Method of Fertility Management (there is currently no app available but there is one in development) I am often asked by my clients about web-based solutions to tracking their cycles when they are travelling or find themselves in other situations where their physical charts are impractical. Fertility Awareness users will be pleased to know that there is a new app on the market, Selene, which has been developed with FAM in mind. In addition to being able to chart the standard fertility markers (cervical mucus, cervical position, and basal body temperature), Selene boasts loads of unique features like the ability to make note of the things that affect reliability the most – like sickness, travel, and disturbed sleep. Selene also allows the user to define their own markers to track patterns in health, mood, libido, and more. The chart tab of the app shows you your cycle in a graph format, while the calendar tab displays it from a monthly perspective. Some of the other highlights of the app include a description of the daily moon phase, an automatic luteal phase calculator, the ability to ask questions about your chart in the “Ask an Expert” section, and a detailed instructions and help section. Selene excels at utilizing the principles of the widely-used fertility awareness method taught in Taking Charge of Your Fertility. Using principles from the book, the app will shade out days of predicted fertility based on the information you enter. It will also calculate an ovulation prediction based on the average length of your cycles. The app highly encourages users to seek additional support and education for their fertility awareness practice, particularly if they are using it for birth control. While Selene offers the most nuanced approach to menstrual cycle charting that I have thus seen (although I can’t claim to have evaluated all the apps on the market), one feature I would like to see added in future versions is the ability to manually choose whether a day is considered fertile (i.e., as indicated by bold stripes on the calendar view) so that those schooled in other approaches to fertility awareness, like the Justisse Method, could have the option of applying our own rules and calculations overtop of the calendar view. The only other critique I have of Selene is that the developer has chosen a dark navy background, which I personally find difficult to view. I’d prefer to see them use a colour scheme that is brighter and easier to read. I am grateful to Selene’s creators for being so thoughtful, thorough and conscientious in the creation of their app. I look forward to seeing what enhancements and updates they integrate into future versions.

Revisiting postmenopausal hormone therapy

July 4th, 2013 by Alice Dan

On June 24, the Journal of the American Medical Association (JAMA) released a report on the Women’s Health Initiative Memory Study of Younger Women (WHIMSY) in the JAMA Network publication JAMA Internal Medicine.

This study is of particular interest because hormone therapy caused significant deficits in cognitive functioning in women aged 65 and older, as documented in the Women’s Health Initiative Memory Study (WHIMS). The “Timing Hypothesis” proposes that, despite the serious risks of hormone therapy demonstrated in the Women’s Health Initiative (WHI) research, therapy with conjugated equine estrogens can benefit women when it is started during the menopausal transition and in early menopause. Last year, a position paper endorsed by 14 medical societies made that claim (Stuenkel, et al, 2012).

Why would so many in the medical profession continue to prescribe hormone therapy, and to believe that hormone therapy is beneficial, in the face of powerful evidence that the risks of such therapy far outweigh the benefits? Probably several reasons:

1) Few other therapies are as effective in relieving women who suffer from distressing symptoms during and after the menopausal transition.

2) Animal and laboratory studies strongly support a positive role for estrogen in cognitive function.

3) The pharmaceutical industry wields tremendous power, and provides financial support to most of the medical societies and research studies in this area.

 It is, as the authors state, “reassuring” that this latest WHIMSY study found neither increased risk nor increased benefit in cognitive assessments an average of 7 years after the study was halted, among the 1,272 participants in the WHI who were 50 to 55 years old when the hormonal therapy was started. However, the lack of cognitive benefit makes one wonder why women would want to risk the serious consequences associated with hormone therapy.

Advocates for women’s health must continue to challenge the ethical and scientific basis for medical practices that can potentially be harmful to women. We need to support research on the mechanisms underlying the effects of hormones on women’s bodies, but also on the sociopolitical forces influencing medical practice.

 

Stuenkel, Cynthia A., Margery L. S. Gass, JoAnn E. Manson, Rogerio A. Lobo, Lubna Pal, Robert W. Rebar, and Janet E. Hall. “A decade after the Women’s Health Initiative—the experts do agree.” Menopause: The Journal of the North American Menopause Society 19.8 (2012): 846–847.

Stopping Depo-Provera: Why and what to do about adverse experiences

April 11th, 2013 by Laura Wershler

Laura Wershler interviews Ask Jerilynn, clinician-scientist and endocrinologist

A screen shot of comments to Laura Wershler’s blog post of April 4, 2012: “Coming off Depo-Provera can be a woman’s worst nightmare.”

With 250 comments – and counting – to my year-old post Coming off Depo-Provera is a women’s worst nightmare (April 4, 2012) I thought it was time to revisit this topic.

That blog post has become a forum for women to share their negative experiences with stopping Depo-Provera (also called “the shot,” or Depo), the four-times-a-year contraceptive injection. (Commenters reporting positive experiences have been extremely rare.) Many women have experienced distressing effects either while taking Depo and/or after stopping it. They report that health-care professionals seem unable to explain their problems or to offer effective solutions. What is puzzling for many is why they are experiencing symptoms like sore breasts, heavy and ongoing bleeding (or not getting flow back at all), digestive problems, weight gain and mood issues when they stop Depo.

This post aims to briefly explain how Depo works to prevent pregnancy, its common side effects and, most importantly, why and what to do about adverse experiences when stopping it.

What follows is my interview with Dr. Jerilynn C. Prior, Society for Menstrual Cycle Research board member, professor of endocrinology at the University of British Columbia, and scientific director of the Centre for Menstrual Cycle and Ovulation Research (CeMCOR) Section 1 explains how Depo-Provera works and what causes its side effects. Section 2  explains the symptoms women are experiencing after stopping the drug.

1) Taking Depo-Provera: How it works and established side effects

Laura Wershler (LW): Dr. Prior, what is Depo-Provera® and how does it prevent pregnancy?

Ask Jerilynn: The term, “depo” means a deposit or injection and Provera is a common brand name of the most frequently used synthetic progestin in North America, medroxyprogesterone acetate (MPA). Depo is a shot of MPA given every three months in the large dose of 150 mg. Depo prevents pregnancy by “drying up” the cervical mucus so sperm have trouble swimming, by thinning the endometrium (uterine lining) so a fertilized egg can’t implant and primarily by suppressing the hypothalamic and pituitary signals that coordinate the menstrual cycle. That means a woman’s own hormone levels become almost as low as in menopause, with very low progesterone and lowered estrogen levels.

LW: Could you explain the hormonal changes behind the several established side effects of Depo? Let’s start with bleeding issues including spotting, unpredictable or non-stop bleeding that can last for several months before, in most women, leading to amenorrhea (no menstrual period).

Ask Jerilynn: It is not entirely clear, but probably the initial unpredictable bleeding relates to how long it takes for this big hormone injection to suppress women’s own estrogen levels. The other reason is that where the endometrium has gotten thin it is more likely to break down and bleed. These unpredictable flow side-effects of Depo are something that women should expect and plan for since they occur in the early days of use for every woman. After the first year of Depo (depending on the age and weight of the woman) about a third of women will have no more bleeding.

LW: What about headaches and depression?

Ask Jerilynn: It is not clear why headaches increase on Depo—they tend not to be serious migraine headaches but are more stress type. Perhaps they are related to the higher stress hormones the body makes whenever estrogen levels drop. Unfortunately, headaches tend to increase over time, rather than getting better as the not-so-funny bleeding does.

The reasons for depression are mysterious to me but this is an important adverse effect. I believe that anyone who has previously had an episode of depression (whether diagnosed or not, but sufficient to interfere with life and work) should avoid Depo.

LW: Although there has been little discussion about bone health concerns on the previous blog post, I think we should address the fact that Depo causes bone loss. How does it do this?

Understanding Research: Media Reports of Research

April 1st, 2013 by Paula Derry

The Huffington Post published a story last week titled “Last Menstrual Cycle Could Be Predicted With New Model”. The story stated that a research study had just been published about a new method for predicting the end of menstruation in which researchers developed a formula for using the levels of two hormones, estradiol and follicle stimulating hormone (abbreviated FSH), to make this estimate. This “new method for predicting a woman’s last menstrual cycle could have broader implications for menopausal women’s health”. Since “in the year leading up to the final menstrual period, women are met with faster bone loss and a greater risk of heart disease”, if the end of menstruation could be predicted, medical monitoring and interventions would become possibilities. The research was also reported as news on the medical website Medscape.

Research results are often reported as news stories, as though these results are facts. However, “dog bites man” and “man bites dog” are facts, but research results are not facts in the same way. They are “evidence” that most often must be evaluated, understood, and put into the context of many other studies. There could very well be disagreement about whether a study’s methods really did accurately make a point, or whether the conclusions the researchers drew from their work were justified. Sadly, it happens all too often that research does not make the point that the headlines claim.

Photo by clarita // morgueFile

Here, we have a study by a respected researcher at a major institution, UCLA, funded by a grant from the National Institutes of Health and other prestigious grantors. However, we do not have the information with which to understand what the researchers actually did. UCLA issued a press release which states that the study “suggests” a way to predict the final period. The Medscape article states that “A new model MAY [my emphasis] help physicians determine how far a woman is from her final menstrual period”.

Suggests? May? I have no idea what this means. As a researcher, I want to look at the published article to see what was actually done. However, the publisher does not make a free copy of the article available. Anyone who wants to look at the published article—a researcher or an informed consumer—would need to pay the publisher $37.00 to access this 20-page article for one day. Predicting the last menstrual period from hormone levels, which is what is claimed, is something other researchers have tried but failed to do, so how these researchers worked with the difficult problems is an important question.

Assume for a moment that the model was a big success, and it did predict the last menstrual period. The idea that this has important implications for women’s health is stated as though it were another fact. However, this is not a fact; this is a complicated and controversial area. Bone density does decrease in the years surrounding menopause, but professionals disagree about how big an effect this has on bone disease. For example, current guidelines recommend testing bone density beginning at age 65, 15 years after the average age of menopause, because this is when the fracture rate has significantly increased. Heart disease risk factors may increase on average in the years surrounding menopause, but professionals disagree about whether menopause is important compared with other factors associated with aging.

Assume for a moment that bone disease really is an important negative health consequence of menopause. Whether interventions would be found that must be started in the year or two before menopause is another speculation. Such interventions might be found or might not. Predicting the last menstrual period, even if the claim is valid that a method to do so has been found, is a long way from preventing disease.

The medical satirist Andrew Vickers wrote an article called “News On Cancer Drug Fails to Raise False Hopes”, which begins: “A recent article on a novel cancer therapy has rocked the newspaper industry by giving a balanced and cautious review of an early-phase trial”. Satirists make extreme statements to make a point. Media reports are often written to sound definite and to portray a study as really important. A cautious approach to medical news is to withhold judgment unless the methodology of the study is clear and the context of the study is understood.

Does it matter that hormonal contraceptives are endocrine disrupting chemicals?

March 6th, 2013 by Laura Wershler

I’ve been wading through State of the Science of Endocrine Disrupting Chemicals – 2012. The 289-page report was prepared by a group of experts for the United Nations Environmental Programme and World Health Organization.

It is dense and complex, but what I’ve been looking for is any acknowledgement that hormonal contraceptives are endocrine disrupting chemicals (EDCs).

Hormonal contraceptives clearly act as EDCs according to the definition used in this report:

An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations. A potential endocrine disruptor is an exogenous substance or mixture that possesses properties that might be expressed to lead to endocrine disruption in an intact organism, or its progeny, or (sub) populations.

Adverse health effects would include, in this context, anything that disrupts the reproductive systems of humans (and wildlife) or contributes to other health problems such as hormone-related cancers, thyroid-related disorders, cardiovascular disease, bone disorders, metabolic disorders and immune function impairment. Hormonal contraceptives certainly disrupt the reproductive system and have been associated with increased risk of cardiovascular events, loss of bone density, decreased immune function and, in some studies, increased risk for breast cancer. Metabolic disorders? Recent research suggests that long-acting progestin-based birth control may increase risk in obese women for Type 2 diabetes.

The only mention I could find of specific contraceptive chemicals is in section 3.1: The EDCs of concern. In a table under the sub-heading Pesticides, pharmaceuticals and personal care product ingredients, two key components of hormonal contraceptives are listed: Ethinyl estradiol, the synthetic estrogen used in most oral contraceptive formulations, and Levonorgestrel, a synthetic progesterone used in combined oral contraceptive pills, emergency contraception, the Mirena IUD, and  progestin-only birth control pills. Levonorgestrel is considered of “specific interest.”

The concern with these chemicals is not the effects they may have on women taking them, but on the possible reproductive impact on wildlife from the excretion of these chemicals into the aquatic environment. It seems ethinyl estradiol and levonorgestrel are considered safe contraceptive drugs when taken by choice to disrupt fertility, but EDCs worthy of concern when such disruption is unintended.

How would it change our perception of hormonal contraceptives if we acknowledged them as endocrine disrupting chemicals? Would we wonder why there is no discussion of how these EDCs might contribute to the health issues considered in the report? Would we ask why hormonal contraceptive EDCs are routinely used to “treat” (meaning only to alleviate symptoms of) endometriosis, fibroids and PCOS – conditions potentially caused by other EDCs?

Another relevant concern addressed in the report is the effect of “estrogenic agents, and their role in breast cancer.” The report states there “is good experimental evidence that estrogenic chemicals with diverse features can act together to produce substantial combination effects.” I have to wonder how hormonal contraceptive EDCs fit into this mix.

Here’s something to ponder. Last week news stories reported that the incidence of advanced breast cancer among young American women, ages 25 to 39, has risen steadily since 1976. Lead researcher Rebecca Johnson was quoted as saying, “We think it is a real trend and, in fact, it seems to be accelerating.” The increase is small in relative numbers, only 850 cases in 2009, but the “trend shows no evidence for abatement.”

Researchers can’t explain the increase. Lifestyle changes, obesity, sedentary lifestyle and toxic exposure to environmental chemicals are offered as possible factors. But what about the hormonal contraceptives many women of this generation have been taking since they were 15 or 16 years old? Surely these EDCs must be considered as potentially contributing factors.

Medicating the Postmenopausal Vagina

March 4th, 2013 by Paula Derry

On February 26, 2013, the Food and Drug Administration issued a news release saying that it had approved a medication called Osphena to treat a problem called postmenopausal dyspareunia (pain during sexual intercourse associated with changes in the vagina after menopause). The medical website Medscape reported that the news release had been issued. How to read these announcements? It seems as though FDA approval should be enough to know that a medication is safe and effective.   However, what are some guidelines in reading and evaluating this announcement?

First, some background: After menopause, when estrogen levels decline, tissues (cells) of the vaginal lining can become thinner, drier (thus providing less lubrication during intercourse), and less elastic or flexible.

This can result in pain during intercourse, feelings of burning or soreness, inflammation, and irritation.

Andreyeva by Ilya Repin // Public Domain via Wikimedia Commons

There are a variety of solutions for dealing with this.  Regular sexual stimulation (intercourse, masturbation) is recommended to keep vaginal tissues healthy.  Water-based lubricants can help reduce discomfort during intercourse.  Expanded views of sexual pleasure that don’t include intercourse might work around the problem. Leaving enough time to become aroused during intercourse (extended foreplay), communication between partners about when sex is painful and when not, can also help. Herbs like dong quai and black cohosh are recommended, especially by complementary/alternative practitioners, although the herbs  lack a research base. A low-dose estrogen applied to the vaginal area (as a cream, tablet, etc.), is effective. Local application minimizes estrogen being absorbed into the bloodstream, traveling through the body, and having effects, some of them potentially negative, distant to the vagina. There is, however, controversy about some estrogen being absorbed.

Now, to the FDA announcement:  The FDA requires proof of a medication’s safety and effectiveness before it is approved.  According to the news release: “Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.”

Notice, first, that the drug’s effectiveness was tested for 12 weeks. This is not an unusual amount of time for such a study, but it is not very much time. Notice also that women treated with Osphena had a “statistically significant” improvement. As I discussed in a previous post, “statistically significant” means “unlikely to have occurred by chance.” In other words, there was evidence that Osphena  really did have an effect, but we don’t know how big an effect—it might be very large or very small.

Safety was established by studying the experiences of women for one year: however, one year is not a long time for side effects to develop. Osphena is a systemic medication. That means it is not applied locally in the vaginal area, it is ingested as a pill so that it travels to all parts of the body in the bloodstream. It is a selective estrogen-receptor modulator, or SERM. SERMs act like estrogen in some places in the body while not in others. The idea is that a SERM like Osphena would act like estrogen in keeping vaginal cells healthy while not acting like estrogen to increase health risks like certain cancers. However, more time than a year might be needed for health problems to show up. Indeed, the FDA news release stated that “Osphena is being approved with a boxed warning alerting women and health care professionals that the drug, which acts like estrogen on vaginal tissues, has shown it can stimulate the lining of the uterus (endometrium) and cause it to thicken…. Women should see their health care professional if they experience any unusual bleeding as it may be a sign of endometrial cancer or a condition that can lead to it.” The FDA announcement also stated that “Common side effects reported during clinical trials included hot flush/flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating” and that Osphena should be prescribed for the “shortest duration consistent with treatment goals and risks for the individual woman.”

Do you love your LARC?

December 12th, 2012 by Laura Wershler

Throughout the contraceptive realm, LARCs are being heralded as the best thing since Cinderella’s glass slipper with little acknowledgement that for many women LARCs are more like Snow White’s poisoned apple.

Nov. 25 to Dec. 1, 2012, was LARC Awareness Week, billed by the California Family Health Council as “a chance to increase awareness about LARCs as a safe, effective, and long-acting birth control method.” Women were invited to contribute video messages on the theme Why I Love My LARC.

This catchy acronym stands for long-acting reversible contraceptive, and the push is on for many more women to choose this form of birth control. Make no mistake, it’s all about control: What the doctor puts in, only the doctor can take out. Ergo, it’s 99% effective. You can quit taking your pills, rip off your patch, or NOT show up for your next Depo-Provera shot. But if you hate the side effects caused by your IUD or implant, you’ve gotta go see a health-care provider to have it removed.

I’ve challenged the Contraceptive Choice Project study that praised the effectiveness of LARCs over the pill, patch and ring. I took issue with the ACOG recommendation that LARCs are the best methods for teenagers. Now there’s more hype with LARC Awareness Week.

According to the awareness campaign, LARCs include the ParaGard (copper) IUD, Mirena (progestin) IUD and Implanon, a non-biodegradable flexible rod, also containing progestin, that is inserted under the skin and left for up to three years. (Here’s a story about the rods going missing in women’s bodies.) Read the patient information about Implanon. Would you agree to have it inserted into your body?

Women who hate Implanon are speaking out. So are women who don’t love their ParaGard or Mirena IUDs. On YouTube, a video by a women with Mirena issues has over 6000 views;  Why I Love My LARC, posted 8 days earlier, has about 100.

The old-school LARC – Depo-Provera – is not on the campaign’s list of LARCs, though it is heavily used in the United States. Holly Grigg-Spall recently reported that “one in five African American teens are on the Depo shot, far more than white teens.” Hmm. Will they all be switched to other LARCs when, or if, they come back for their next shot? Perhaps Depo is not on the list because women can discontinue this contraceptive without clinician intervention. But it’s probably because Depo causes bone density loss – and because this LARC is not a lark. Women are sharing their Depo stories on another re:Cycling post:  Coming off Depo-Provera can be a women’s worst nightmare. You can find more bad news about this LARC than any other.

What about getting your LARC removed if you hate it instead of love it? One re:Cycling blogger shared what happened when she wanted her ParaGard IUD removed:

I HATED the thing but the nurse who was supposed to take it out tried to talk me out of it for a good 20 minutes. Finally I was like ‘”Why do you want me to keep this item in my uterus so badly?” And she said, “I just don’t want to see you get rid of your very effective birth control.”

This is not the only reason why women who end up hating their LARCs will be discouraged from rejecting them. The Affordable Care Act requires all health plans issued on or after August 1, 2012 to provide no-charge access to FDA-approved LARCs. What’s it going to take to convince health-care providers to remove an expensive contraceptive – provided for free – that was supposed to last for three to 10 years?

Maybe a YouTube video about Why I Hate My LARC will help make it as easy to get rid of one as it now is to get one.

Hot Flashes Are Weird

November 12th, 2012 by Paula Derry

I have two pretty contradictory sets of opinions about hot flashes. In a previous blog post, I emphasized one of them. Namely, that flashes are a mind/body phenomenon in which a woman’s interpretation of her physical experiences are central to her being distressed or not, of being able to cope or not, of what an experience is and means. A woman can identify her “real” self with her thoughts or her body, or she can experience her embodied self as a totality. In my first set of attitudes, the diversity of physical experiences is part of the mix: The same term, “hot flash,” is used for a wide family of experiences that range from mild to unbearable, from heat to heart palpitations, from empowerment to anxiety. However, in my second set of opinions, physical experience is front and central, and my thoughts can be summarized as follows: Hot flashes are weird.

In a conventional view, flashes are simply something that happens because of the hormonal changes surrounding menopause. They are often defined as a transient feeling of heat, sometimes accompanied by sweating or the skin turning red, that typically lasts a few minutes but can persist up to an hour. Flashes are most common in the years surrounding menopause but can begin many years before or occur many years after the final menstrual period. One theory is that fluctuating levels of estrogen affect a part of the brain that controls heat regulation. As a result, small changes in temperature are interpreted by the brain as meaning that the body’s temperature is outside the normal range; the hot flash is the body’s attempt to cool the body down. Alternatively, perhaps the hormonal imbalance affects the brain or other endocrine glands in other ways, or perhaps some women are simply more sensitive to these changes.

However, the experience of flashes is complex. A woman who is overheated for other reasons may not feel like a woman having a hot flash. A flashing woman might feel like she is on fire. Or she may feel hot only in an isolated body part, like her back or earlobes. Or the feeling of heat may start in one part of the body (like her head or upper back) and travel. Some women may not realize their feeling of gentle warmth is caused by a flash until later. Further, there are experiences in addition to that of warmth. The experience might feel like anxiety rather than heat. There may be a sharp physical shock or jolt. Some women, for example, may wake up in the middle of the night with a shock of anxiety and wonder what has threatened them. Some women report other associated sensations such as a racing heart, nausea, and breathlessness. Some feel dizzy, anxious, and unable to concentrate. Others experience cognitions and feelings such as empowerment, anxiety, and catastrophic thoughts.

Flashes are basically not understood. Beneath the scientific generalities, there is no specific understanding of what underlies flashes. They do clearly have something to do with estrogen: they increase in frequency in the years surrounding menopause, and treatment with a hormone medication is helpful. However, while fluctuating estrogen levels are assumed to be causal, clear evidence of this has been notably lacking. Further, flashes are found during the menopausal transition and postmenopausally, two very different hormonal situations, but are not a widespread phenomenon during premenstrual hormone fluctuations. For the minority of women with severe symptoms, there is no understanding that would lead to correction of underlying problems beyond symptomatic treatment with medications like estrogen. Why would a brain center regulating body heat be affected in some women but not others or in the same woman only sometimes? There are speculations that estrogen is needed for brain general health and proper neurotransmitter balance or that some women are “more sensitive” to normal changes in hormone levels. It seems that additional factors must also be at play. The large cross-cultural differences in flash frequency and the large placebo effects of medications are not understood, neither is the role of stress or other psychological or situational factors.

Is Hormonal Literacy Important in a Counseling Session?

October 19th, 2012 by Ashley Ross

When we sit with our clients – whether it’s a medical consultation, a therapy session, a group program or even spiritual guidance – what happens when we include a woman’s cyclic nature in the conversation?

As a holistic reproductive health coach using the Hakomi somatic counseling method, this question is not only unavoidable but inevitable.

Hakomi is a therapeutic method that uses mindfulness in our present time experience to discover unconscious beliefs that either resource or limit us. Put another way, we bring a woman’s awareness to what is happening in her body as we’re consulting with her. This is done with the understanding that our bodies are as much a part of our experience as our cognitive experience (how we make meaning) but they have a less perfected filtering and editing capacity, making them a wonderfully effective access route to our unconscious – our experience outside our awareness.

Many of my clients come to me for help with their emotional hormonal symptoms (perimenopause, PMS). Below are a few different ways I work in this hormone/psyche/somatic interface. I thought this might be a place for us to share what we’ve discovered.

Knowing Where She’s At

I begin each session by establishing which phase of her monthly cycle and/or life-cycle she’s in. We explore how she experiences these phases (which initially requires teaching tracking and observation skills). I also find it extremely helpful to find out what birth control she uses to ascertain whether she is using endocrine disruptors.

Her Relationship to Her Cycle

We get to know what beliefs she has about her cycle and her body. Many core beliefs about the Self reside in her relationship with her body and can show up in how she experiences her period, her birth control choices, how she inhabits different parts of her body – specifically her reproductive organs and pelvis, etc. (I like the work of Tami Kent on this last point). Many issues of self-regard, self-compassion and agency might also be expressed through this relationship.

Menarche

We explore her first period experience; for example, how old she was, what was happening in her life at that time and the messages she got leading up to and including her first period. These might include difficulty in accepting her sexuality; anger and resentment towards the masculine, or the feminine; shame, confusion, disappointment or rage about her menstruating body; relief and excitement about being a woman; etc. We also explore her significant relationships at that time – with mother, father, sisters, brothers, grandmother etc. We note whether she experienced any loss of relationships because of her menarche. We offer her the “missed experience” of acceptance of her womanhood, fertility and sexuality (with gender-identity appropriateness).

Normalizing the Fluctuations

We discuss variations in energy, temperament, sexuality, mood, “liminal” state (see Alexandra Pope’s Wild Genie), etc. through her cycle. She learns to recognize her unique patterns. We explore any fears/judgments/beliefs about being “unpredictable” or “inconsistent”, specifically in relation to expectations she might have for herself.

The Resource of Hormonal Literacy

We point out new signs and beliefs as she begins to integrate her hormonal experience. for example, moments of self-compassion, nonjudgmental, embodiment, empowerment, etc. We work somatically to create new neural pathways that integrate her developing hormonal literacy.

These are a few areas that I feel warrant further discussion and examination in how we include a woman’s hormonal experience in our interactions with her in a session. There are more, of course, like the counselor’s relationship to hormones and menstruation (counter-transference) as well as bringing hormone awareness to treatment with addiction or trauma. Rich stuff.

What I’ve noticed by including this interplay between hormones, psyche, and the body is the phenomenon of how awareness changes a woman’s experience. When she connects the dots between her hormonal cycle and her experience, it not only empowers her but shifts her hormonal experience itself.

I know we all look forward to the day when our hormonal and somatic awareness are so integrated, they become the water we swim in – that great day when we are not appreciated and valued regardless of our hormones but because of them. Until then, I believe we can best serve women by including hormonal literacy in our work together.

When Can We Write the Obituary for the Critical Timing Hypothesis?

October 12th, 2012 by Chris Hitchcock

What Happened?

The highlight of last week’s meeting of the North American Menopause Society (NAMS) meeting was a presentation of the primary results of the KEEPS study (Kronos Early Estrogen Prevention Study). A press release describing the findings, along with a list of FAQ (frequently asked questions), is available on the Kronos website. KEEPS was designed to confirm the critical timing hypothesis by looking at the use of menopausal hormone therapy in healthy women who were 6-36 months from their last menstrual period. Primary outcomes were progression of two atherosclerosis markers: carotid artery wall thickness (cIMT) and coronary artery calcification (CAC). In both cases, there were no statistically significant differences among the three groups (two hormone therapy formulations and a placebo group). The study failed to meet the stated goals by the stated criteria. Medical and popular coverage of these preliminary, non-peer-reviewed results have been almost uniformly positive, advocating renewed use of estrogen as menopausal therapy to women, provided they are young and healthy.

The timing hypothesis1 was born out of the collective cognitive dissonance following the unexpected findings of the Women’s Health Initiative, which failed to confirm the widespread belief that menopausal hormone therapy (specifically, estrogen) would protect menopausal women from cardiovascular disease.

The birth of KEEPS

Soon after the results of the Women’s Health Initiative were published, the discredited idea of menopausal hormone therapy for the prevention of cardiovascular disease was resurrected in the form of the critical timing hypothesis. In 2005, the KEEPS study was launched with much fanfare in the popular press and the medical literature. The lead editorial2 in the journal Climacteric heralded it as a move “[t]owards safer women, safer doses, safer routes and safer timing of administration of safer menopausal therapies,” and the journal invited an article describing the study design3.

Study Design

KEEPS is a “prospective, randomized, controlled trial designed, using findings from basic science studies, to test the hypothesis that MHT when initiated early in menopause reduces progression of atherosclerosis. KEEPS participants are younger, healthier, and within 3 years of menopause thus matching more closely demographics of women in prior observational and epidemiological studies than women in the Women’s Health Initiative hormone trials. KEEPS will provide information relevant to the critical timing hypothesis for MHT use in reducing risk for CVD.”4 The target sample size was 450 women completing the study, with a goal of at least 150 women in each arm. The recruitment goal was 720 women.

Rather than using the synthetic hormones (conjugated equine estrogen, CEE and medroxyprogesterone acetate, MPA) from the WHI, KEEPS included more “natural” hormonal products, comparing oral conjugated equine estrogen (o-CEE, derived from pregnant mares’ urine, and taken as a pill – Premarin, 0.45 mg) with transdermal estradiol (t-E2, taken by patch – Climara, 50 mcg). Estrogen taken alone causes endometrial cancer; KEEPS added oral micronized progesterone (OMP, 200 mg for 12 days per month), which is identical to the human hormone molecule.

The three arms were:

  1. PLACEBO – placebo pill, placebo patch, placebo OMP
  2. o-CEE + OMP – active pill, placebo patch, active OMP
  3. t-E2 + OMP – placebo pill, active patch, active OMP

The purpose of KEEPS was to test the critical timing hypothesis, that is, to answer the question:

Does estrogen therapy, when administered during the critical timing period, protect women from cardiovascular decline?

A study of this size and duration in healthy young(er) women cannot hope to address clinical outcomes, such as stroke, heart attack and the like. Therefore the study had two surrogate markers of atherosclerosis (a part of cardiovascular health) as primary outcomes:

  1. Rate of change in the thickness of the wall of the carotid artery (CIMT)
  2. Amount of arterial calcification of the coronary artery (CAC)

Both measures have strong evidence linking them to future cardiovascular disease.

Recruitment and Retention 4, 5

KEEPS met recruitment targets (727 randomized women at 8 centres) and exceeded retention targets (466 women completed all 4 years of the trial, and an additional 118 women discontinued study medication but continued to be followed for 4 years).

Hormone Imbalance: Breaking the Silence

September 5th, 2012 by Elizabeth Kissling

Guest Post by Leslie Carol Botha Women’s Health Freedom Coalition Coordinator, Natural Solutions Foundation

I still remember the first Society for Menstrual Cycle Research Conference I attended in Tucson, AZ in June, 1999. The statement that made the most impact was the collective concern that in ten years there might no longer be a menstrual cycle. It turns out the truer words were never spoken.

In the past 40 years, the pharmaceutical industry has spewed out and packaged and repackaged so many synthetic hormone contraceptives – pills, injections, and implants that virtually eliminate the menstrual cycle.  It also amazes me that in the 30 years I have been involved with the women’s health movement condoms and spermicide are still the safest and most effective contraceptive on the market.

However, a new trend is emerging as condoms and birth control pills are being pushed on the back burner because of ‘human error’. Women and men are not always diligent or careful about condom use, and many girls and women forget to take their pills.  What is now being prescribed to adolescent girls – whether or not they are sexually active — are implants and injections. Health considerations are not taken into consideration, nor are hormone levels. Somehow the pharmaceutical industry still views this as a one-size-fits-all prescription for all women, no matter their age of their state of health.

Menstrual cycle advocates are most aware that birth ‘control’ is about control…controlling the woman’s body with potentially harmful synthetic hormones. What has been overlooked are education and natural methods of fertility awareness.

While our focus recently has been on the politics of birth control, another ugly monster has reared its head and that is the silent epidemic of hormone imbalance. Not only is this the result of taking synthetic hormones for birth control but our environment, our foods, and water supplies are filled with estrogen mimickers upsetting the delicate orchestration of hormones in our bodies.

Another concern is the excess estrogen stored in women’s bodies and passed on genetically to their offspring.  It is possible that their children are hormonally imbalanced at birth.

Either way, the damage has been done. I believe we are at the tip of the iceberg in this silent epidemic and that hundreds of thousands of women are being misdiagnosed and over-prescribed. In most cases, thyroid imbalance is not considered as a cause of depression, and the prescribed fix is generally Prozac or a higher dose of synthetic hormones.

In 2009, I posted an article to my blog, from eHow editor, Shelly Macrea titled: What is Hormone Imbalance?, a very informative article and probably one of the first pieces for a general audience on the myriad of conditions that hormone imbalance can cause.

At the time I had three responses (with an average of 30,000 unique visitors a month.) In June of this year, another post on the article (which by this time was buried in my archives) appeared from a woman suffering anxiety due to hormone imbalance. And then another post appeared and I decided to bring the article out of the archives and re-post it. What ensued was a steady stream of women commenting on almost a daily basis on their extreme anxiety and depression and the myriad of misdiagnosis and drugs they were prescribed. I am posting the link here so that others can read what I believe should be of concern to all of us: Hormone Imbalance Anxiety, A Precursor to Other Health Issues.

In March of this year, I posted Laura Wershler’s article Coming off Depo Provera Can Be a Woman’s Worst Nightmare. Once again, truer words were never spoken. More and more women are now posting about their experiences on this drug – and the ensuing hormone imbalance and health issues.

Women are suffering.

This is an insidious ‘War on Women’. On the one hand we have had to fight for our reproductive rights and the availability of birth control – on the other hand it is the same birth control that is slowly killing us.

Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.