Blog of the Society for Menstrual Cycle Research

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.  Continue reading...

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Posted in Amenorrhea, Birth Control, coming off the pill, Dysmenorrhea, Health Care, Hormones, Menorrhagia, Menstruation, Ovulation, Perimenopause | 21 Comments »

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.

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Posted in Health Care, Hormones, Media, Menopause, New Research | No Comments »

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.  Continue reading...

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Posted in Birth Control, Fertility, Hormones, Menstruation, Pharmaceutical, Reproduction | 25 Comments »

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.”  Continue reading...

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Posted in Menopause, Pharmaceutical, Sex | 4 Comments »

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.

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Posted in Activism, Birth Control, coming off the pill, Girls, Health Care, Hormones, politics | 6 Comments »

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.  Continue reading...

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Posted in Hormones, Menopause | 2 Comments »

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.

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Posted in Hormones, Menstruation | 3 Comments »

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:  Continue reading...

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Posted in Hormones, Menopause, New Research, Perimenopause | 6 Comments »

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.  Continue reading...

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Posted in Birth Control, coming off the pill, Hormones, Pharmaceutical | 1 Comment »

The Biology of Reproduction Isn’t Just About You

July 23rd, 2012 by Paula Derry

Photo by Minyoung Choi // CC 2.0

A scientific paper was recently published which looked at how shifting patterns of daily light and darkness affect pregnancy in mice.   The authors were interested in this question because studies have suggested that humans who experience such patterns, such as shift workers or women who travel repeatedly across time zones, have reduced fertility. In their study, pregnant mice were divided into three groups. All groups had 12 hours of light followed by 12 hours of darkness.  The control group had the same pattern throughout the 21 days of pregnancy.  The other two groups had shifting patterns.  In one, the 12 hours of light started six hours earlier every five days (phase advanced group); in the other, six hours later (phase delayed group). In the control group, 90% of the mice had successful pregnancies and deliveries; in the phase advanced group, 22%; in the phase delayed group, 50%.

Circadian rhythms is the general term for biological activities that have a 24-hour cycle, like sleeping and waking, or like hormones whose amounts vary during the course of a day. There are many circadian rhythms in humans, animals, and plants.

They are internal, determined by the physiology of the animal or plant. However, they are also entrained (synchronized with) environmental events like the amount of light at night vs. during the day. This entrainment means the rhythms match what is going on in the environment and also can adjust to environmental change. In the pregnant mouse experiment, the light shifts were so large they disrupted the internal circadian timekeeper, which had cascading effects on mouse physiology and success in maintaining a pregnancy.

There are also many physiological rhythms that mesh with environmental patterns on longer or shorter time scales, for reproduction as well as many other aspects of biology. Zucker (1988), for example, found an annual rhythm to whether the amounts of a hormone called luteinizing hormone (LH) had a feedback relationship (that is, interaction) with the amounts of estrogen in ground squirrels. Typically in a mammal, LH increases estrogen production, and then when estrogen levels reach a high point the LH surges which initiates ovulation. For ground squirrels, who only become pregnant during January to March instead of having a regularly repeating cycle throughout the year, this relationship between hormones only exists during the breeding season. If the ovaries of females are surgically removed (so that their bodies don’t make estrogen), LH levels still go up to initiate the breeding season at the correct time of year; that is, levels of LH appear to be controlled by some environmental factor.

There are also social influences on the biology of reproduction in animals. Nelson (1999) summarized some of them: If four or more female mice were housed together in a cage, their cycles occurred less frequently. If they were then exposed to a male, they ovulated at the same time. In a study of albino mice, if a strange male was introduced into the cage of pregnant females, the females spontaneously aborted about 25% of the time. If the male who impregnated the female was re-introduced into the cage, there were no miscarriages. Female rats that were handled daily by researchers reached puberty at an earlier age than did rats who were not, and mice housed alone reached puberty sooner than mice housed with other females.

What does this mean for humans? There are not necessarily direct correspondences between animal and human research. Sometimes human physiology is simply differerent; sometimes, exactly the same. In addition, humans may have many influences where animals have fewer, so big, determining effects in animals may be mere suggestions in humans, one factor among many. On the other hand, the circadian research I discussed above was suggested by the possibility that shift workers and frequent travelers have fertility problems. Many social influences on human menstruation — synchronized menstrual cycles among college roommates, effects of stress — have been reported.

The possibility that intrigues me is this:  We are individuals, but we are also intrinsically part of larger environments. Reproductive biology is about our inner organization of hormones, brain chemicals, goals and interests, but it is also about the viability and value of conception in specific social groups and physical environments. Our physiology is inside our skins, internal to us, but is also related to maintaining a state of balance with our physical and social environments.

References

Nelson, R.  (1999). An introduction to behavioral endocrinology.  Sunderland, MA: Sinauer.

Summa, K., Vitaterna,M., & Turek,T.  (2012).  Environmental perturbation of the circadian clock disrupts pregnancy in the mouse” PLoS One 7(5): e37668.  doi:10.1371/journal.pone.0037668

Zucker, I. (1988). Neuroendocrine substrates of circannual rhythms.  In D. Kupfer, T. Monk, & J. Barchas (Eds.), Biological rhythms and mental disorders (pp. 219-252).  New York: Guilford.

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Posted in Fertility, Hormones, New Research | 4 Comments »

The Eternal Feminine: Focused, Goal-Oriented, Practical, and Loving

April 30th, 2012 by Paula Derry

Visiting colleges became part of our repertoire of family trips back when my daughter was a senior in high school.   We visited many schools to get a sense of the range of possibilities that existed.   As was typical, Vassar offered a tour of the campus for groups of prospective students and their parents, led by tour-guides who were undergraduate students.  Vassar’s tour had one unique feature.  An original campus building, which dated to the post-civil war era, had an exceptionally wide hallway.  This, we were told, was because the all-woman student body needed to be able to walk back and forth repeatedly in the halls in their wide skirts, as part of a college program in physical fitness. Vassar, founded on the idea that the education of women should equal that of men, had a program of physical culture to offset criticisms that the school was endangering women’s health by educating them.

Sheila Rothman describes Vassar’s history in her book “Woman’s Proper Place,” published by Basic Books in 1978.  The common wisdom in the second half of the 19th century was that people have a limited amount of biological “vital energy.”  Rothman (p.24) quotes a contemporary physician:  ”Woman has a sum total of nervous force equivalent to a man’s” but the force is “distributed over a greater multiplicity of organs…The nervous force is therefore weakened in each organ…it is more sensitive, more liable to derangement.”  Menstruation and pregnancy were times of special danger, when the demands on her system were greater and the possibility of physical and mental disorder increased.  Menstruation was a time when women were irrational, even insane.  Caution, however, was always called for, as when intellectual activity or other exertion used up nervous energy.  Thus, when Vassar was founded, a program was put in place to overcome women’s predisposition to illness through a structured environment and programs of physical exercise.  Later, the Association of Collegiate Alumnae conducted a survey to provide research evidence as to whether female college graduates were normal.

Image by Thiophene_Guy // CC 2.0

Back in the Vassar of the present, our student tour guide wondered:  “How could anyone believe anything so silly?” It’s true that we no longer talk about a “vital force.”  Yet, broad generalizations about the nature of women and reproductive physiology continue to exist that have an air of plausibility, based today on a different scientific language, one of hormones, neurotransmitters, and other players.   Not very long ago, menopause was defined as an “estrogen deficiency disease” that had a uniquely powerful effect on health.  Heart disease was a disease of civilization for men and a disease of the ovaries for women.   The idea that the menstrual cycle destabilizes women’s minds, creating mood and intellectual changes, continues to exist.

One of my favorites is the idea that women are somehow receptive, loving, and self-denying because of their maternal role, which is somehow mediated by estrogen.  Thus menopause may be said to be a time that women regain the ability to focus more on themselves, liberated from a physiological preparedness for reproduction and its needs.   Pregnancy is a dreamy time when women are moody and unable to think clearly.

Sure, mothers are receptive, loving, self-denying, but they are also many other things.  I love being a mother.  My relationship with my daughter has been powerful, unique, and wonderful.  However, I know that a mother who is lost in a dreamy connectedness to her child or reflexively puts her child before herself can’t do everything she needs to do.   A mother is emotionally connected to her child but also must be an individual who perceives the child accurately, as a separate person, in terms of the child’s motivation and perspective, in order to provide both a sense of connection and the mirroring needed for a child’s emotional development.   Further, children misbehave, make mistakes, and must be taught all kinds of things; mothers must have clear-headed, pragmatic, problem-solving skills.  Continue reading...

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Posted in Hormones, Menstruation, Pregnancy, Reproduction | No Comments »

Coming off Depo-Provera can be a woman’s worst nightmare

April 4th, 2012 by Laura Wershler

Need proof that women are sometimes desperate for information and support when it comes to quitting hormonal contraception? You need look no further than the 100 plus comments in reply to an old blog posting at Our Bodies Ourselves: Questions About Side Effects of Stopping Contraceptive Injections.  The comment stream – a litany of woes concerning women’s discontinuation of Depo-Provera – has been active since Nov. 2, 2009.

On March 29, 2012, Rachel, author of the post, wrote a follow-up piece in which she laments: “Although a quick internet search finds many women complaining of or asking about post-Depo symptoms, there isn’t much published scientific evidence on the topic.” Beyond research about bone density and length of time to return to fertility, little is known about the withdrawal symptoms women have been commenting about.

Depo-Provera is the 4-times-a-year birth control injection that carries an FDA “black box” warning that long-term use is associated with significant bone mineral density loss.  Never a fan, I made a case against this contraceptive in a paper for Canadian Woman Studies, published in 2005. The comments on the OBOS post indicate that many women took Depo-Provera without full knowledge of the potential for serious side effects while taking it, or of what to expect while coming off the drug.

Considering that Depo-Provera completely suppresses normal reproductive endocrine function, it is not surprising that many women experience extreme or confusing symptoms once stopping it. Take Lissa’s comment for example, posted on February 21, 2011:

Omg I thought I was tripping. I have been on depo for a year and stopped in jan. My breasts constantly hurt, I put on weight, have hot flashes, and sleeping problems. I pray everyday my cycle returns and stops playing with me. I only spot lightly.

Two and a half years after publication, the original article continues to garner monthly comments. I’ve read most of them and have yet to see one that offers concrete advice or a referral to resources that provide information and support to women looking for both. One such resource is Coming Off The Pill, the Patch, the Shot and Other Hormonal Contraceptives, a comprehensive, clinical-based guide to assist women transition back to menstruation and fertility, written by Megan Lalonde and Geraldine Matus.

Lalonde, a Holistic Reproductive Health Practitioner, and Certified Professional Midwife, helps women establish healthy, ovulatory cycles after using hormonal contraception. She says that women who’ve used Depo-Provera generally experience the most obvious symptoms and have the hardest time returning to fertility.  She finds that every client’s experience is different and will be affected by the status of their cycles before taking the drug, and their overall health. “It can take time to regain normal menstrual cycles, from a few months to 18 months, in my experience,” says Lalonde. “Some women have minimal symptoms while their own cycles resume, while others might have significant symptoms, including mood changes, unusual spotting and breast tenderness.”

The comments to the Our Bodies Ourselves blog post demonstrate that many women are not finding the acknowledgement and support they need to understand and manage the post-Depo transition. Some are disheartening to read, like this comment by Judy from April 12, 2011, and this recent one posted by Melani on March 21, 2012.

In my last re: Cycling post, I asked for input on the Coming Off the Pill Mind Map I created. I’ll be making a few revisions thanks to the thoughtful feedback readers have provided. I had assumed that this guide would be applicable to all methods of hormonal birth control but, after reading these women’s comments about their Depo-Provera experiences, it appears this contraceptive may require its own branch on the mind map.  Continue reading...

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Posted in Birth Control, coming off the pill, Health Care, Hormones, Menstruation | 283 Comments »

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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.