Blog of the Society for Menstrual Cycle Research

Cause and Effect

November 11th, 2013 by Paula Derry

Does menopause cause an increase in health problems ranging from heart disease to bone disease to psychological depression? One issue is that many of these claims have been criticized as being overblown both by professionals within the medical community and by critics outside it. Another issue is that when problems are linked to menopause, the suggested solution has often been estrogen supplements (postmenopausal hormone therapy)—since after menopause a woman’s body produces far less estrogen—rather than seeking more complex causes, solutions, and mechanisms.

For example, although heart disease has many causes, during the 1990s many professionals recommended hormone therapy as being uniquely effective at preventing heart disease. At one time, a middle-aged woman who was depressed ran the risk of a professional assuming that she was suffering from a hormone imbalance without a careful evaluation of her distress.

While there is more attention today to looking at what causes problems and the best way to solve them, there is still a fundamental lack of understanding of basic processes. Even if menopause is linked to a problem, that doesn’t in itself tell us the mechanism by which this happens, or the best way of solving the problem. Suppose, for example, it had turned out that research established (it hasn’t, but suppose it had) that a woman’s risk of heart disease increases because of menopause. If this was because changes in estrogen levels result in changes in a woman’s metabolism, then lifestyle changes might solve the problem by revving up her metabolism even though a hormonal change caused it. Further, some other cause might be present. Perhaps some women who feel old or are busy become less physically active at midlife. Or perhaps some women who are depressed start eating more dessert. Or perhaps (as seems to be the case) heart disease risk simply increases as people get older.

For a wide variety of problems related to menopause, it would be great if more research looked at basic causes, complex mechanisms, and individual differences.

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.

What Is Holistic Health?

September 16th, 2013 by Paula Derry

What is a holistic approach to health? To me, this is something different than using bio-identical hormones, practicing yoga, or seeking help from an acupuncturist. Sometimes, practitioners using complementary/alternative or integrative-medicine methods have as entrenched a disease model of the reproductive system as anyone else. For example, some practitioners talk about “treating” menopause itself, especially about treating “hormone imbalances” caused by the “shutdown” of the ovaries, accepting a theory that menopause is a disease or intrinsically unhealthy. A similar idea may be applied to normal changes through the menstrual cycle or premenstrual changes that are distressing.

To me, a holistic or integrative approach involves attitudes or understandings about what health is. Feeling healthy is the baseline against which dis-ease or disease contrasts. Sometimes disease results from just-one-thing (like a hormone imbalance), but, more typically, many factors are involved. For example, menopause isn’t unhealthy in and of itself, but sometimes unhealthy or distressing complications of menopause develop based on many factors. For example, treatments for menopause-related, premenstrual, or other reproductive issues often involve lifestyle changes (in diet, activity, etc.) in addition to whatever other approaches are used.

Here is a copy of a handout I use to provide an introductory overview of holistic health:

What Is Holistic Health?
Paula S. Derry, Ph.D.

Health is more than not having any diseases.

The World Health Organization defines health as “complete physical, mental and   social well-being and not merely the absence of disease or infirmity.”

Feeling healthy is an actual experience.

This may include a feeling of well-being; feeling solid, whole, at home in our bodies; feeling like we can move forward to accomplish our personal aims and goals, feeling physically strong and energetic, etc.

We feel healthy in the here-and-now.

Health involves being able to maintain our balance in the face of adversity.

Being able to cope, being resilient, being adaptable, asking for help when it is needed, etc.

Health involves the whole person and a balance among all our parts.

Physical health, mental well-being, and spiritual needs are all interconnected and play a role in overall health.

There is a natural vital energy in all living things.

Health also involves our relationship to all that is around us.

For example, relationships with other people and the physical environment. Some would put spiritual experience here.

Understanding illness involves understanding the whole person.

A person recovering from illness is restored spiritually, psychologically, and physically.

Maintaining health may mean getting help from a health professional or healer; engaging in activities for the purpose of preventing illnesses (like a diet to prevent diabetes); or having a satisfying lifestyle that is healthy and as a side-product maintains health (like if you practice yoga because you enjoy it, and it ends up helping to reduce stress).

What are basic needs, and what is a healthy lifestyle? It’s individual, but can include:

Activity (including exercise)



Social Relations

Meaningful existence


Spiritual Connectedness


With regard to illness:
The body wants to heal itself.

Sometimes it needs a push in the right direction or other help restoring the ability to heal.

Holistic practitioners help the body regain its ability to heal itself. Sometimes this is not what is needed or enough, as when cancer or other illnesses require different kinds of help.

Some important parts of healing:

Restoring conditions so the body can heal itself; restoring balance to the body/mind/spirit; using the natural vital energy to help the body heal itself; attending to lifestyle; the relationship between a practitioner/giver and the client is important. Some methods:  herbs, acupuncture, touch, breathing, talk, etc.

Understanding Research: (Meta)Theoretical Frameworks

August 19th, 2013 by Paula Derry

Research results are often reported by the media as stand-alone statements and as though they are facts. “Slim women have a greater risk of developing endometriosis than obese women.” “Respiratory symptoms vary according to stage of menstrual cycle.” In previous blogs, I have said that a reader needs to understand research methods and basic concepts found in statistics in order to make sense of what results really mean. This blog is about another ingredient that goes into making sense of research. Metatheoretical frameworks, basic ideas of how the world works, are important influences on how researchers choose what problem to study, choose the methods with which to study it, and choose how to interpret the results.

The context of research is always stated in research articles. Articles always include a write-up of previous work, discussing what has been done and what unanswered questions remain. This sets the stage for why the research being reported is interesting and important. However, what I want to discuss are more general, often implicit, basic assumptions. Even what seem to be brute facts are understandable as such only within a given set of basic assumptions or paradigms. Paradigms guide thinking, but change over time.

Thus, as discussed by Sheila Rothman, a  nineteenth century metatheory was that assertiveness and activity are dangerous for women. As stated in a more specific scientific theory: All people have a limited amount of nervous energy; this nervous energy is distributed over a greater number of organs in women than in men (because of their reproductive organs); therefore, all of women’s organs are more “sensitive and liable to derangement (p. 24).” It was concluded from these ideas that exercise and exertion are dangerous for women; further, mental exertion, such as going to college, should be avoided. Rothman describes case studies written up by physicians of women harmed by exertion and cured by rest. In this context, designing research to evaluate whether college harms women appeared to be a sensible, even important undertaking. So did structuring a college curriculum to avoid precipitating debility or insanity.

What are some of our current basic paradigms? One example: Menopause is senescence and reproductive physiology is central to women’s health. It follows from these premises that menopause or the transition to menopause are key factors in the development of chronic illness; research addresses what harm is created or, alternatively, whether these premises are correct. Another example: Cyclic changes in mood, intellect, and energy during different stages of the menstrual cycle are very important, especially to understand distress. Alternatively, a healthy menstrual cycle suggests that a woman is physically healthy.

Research I am conducting with Greg Derry addresses another metatheory about the menstrual cycle. Periods are most often described as cyclic, recurring in a regular repetitive manner (“every 28 days”). However, modern systems theorists know that there is a different kind of system (a “nonlinear dynamical system”) that by its nature generates a little bit of unpredictability and by its nature interacts with other systems (“is an open rather than a closed system”). Our research has provided evidence that the menstrual cycle is a nonlinear dynamical system. This means, among other things, that menstrual periods would be expected to be a little bit irregular with an occasional extreme cycle length.

The psychologist Robert Abelson reminds us that research is an ongoing process of discussion. Understanding research means joining the conversation.

Fun Facts About Menstruation

July 22nd, 2013 by Paula Derry

Menstruation occurs because the inner lining of the uterus (called the endometrium) has undergone changes that prepare for pregnancy. If there is a fertilized egg, the uterus will be able to provide a hospitable and nurturing environment. If a woman doesn’t become pregnant, the inner lining is shed, in a discharge that includes cells, fluid, and blood; we call this menstruation.

Fun fact #1:  Menstruation is a rarity, perhaps an oddity, in nature. Most animals don’t prepare a lining in advance just in case pregnancy occurs. They have hormonal cycles, which are called estrus cycles, but not menstrual periods. Most primates (monkeys, apes, and us) menstruate (Nelson, page 262).

Fun fact #2:  The endometrium is shed in layers during menstruation (Voda, page 62). That is, although cells are dying, blood vessels are leaking, and other changes are occurring, this breakdown occurs in the form of shedding of layers, not in a random cataclysm.

Fun fact #3:  Most of the endometrial material that is eliminated is resorbed, not menstruated (Voda, page 62). That is, your body typically clears away material that is no longer useful or is waste. Suppose, for example, you bang your finger hammering a nail and get a bruise. Over time, the black-and-blue area at your injury, with its injured cells, blood, and other material, returns to normal as your body clears away the debris. Similarly, according to Voda, most of the endometrial material is resorbed; menstrual flow is a minority of the material being shed.

Fun fact #4:  Why do women (or monkeys and apes, for that matter) menstruate?
Answer:  There are theories, but no one knows.


Nelson, Randy. An Introduction to Behavioral Endocrinology. Sinauer Associates.
Voda, Ann. Menopause, me and you. Haworth Press.

Ethics in Wonderland: The SUPPORT Study

June 24th, 2013 by Paula Derry

Arthur Caplan is a well-known ethicist, the head of the Division of Medical Ethics at New York University’s Langone Medical Center. On June 11, 2013, Caplan posted an article called “Get real: No need to overdo risk disclosure” on the medical website Medscape. According to basic ethical standards, subjects in research projects are supposed to give written informed consent, which means among other things that they are informed of possible risks that a decision to participate in the study might cause. The Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services criticized researchers in a large project called SUPPORT for failing to clearly disclose the study’s risks. In his Medscape article, Caplan disagreed with OHRP and argued that strict, inappropriate requirements for consent discourage important research. His sentiments were echoed in a recent editorial in the New England Journal of Medicine, a major respected journal. In contrast, SUPPORT is criticized in a New York Times editorial entitled “An Ethical Breakdown” and by watchdog organizations like the Alliance for Human Research Protection and Public Citizen (many of the critical documents are on the Alliance for Human Research Protection website).

Here’s some background: SUPPORT was a large study of how best to treat very premature babies. These babies often need to be given oxygen to help them breathe. However, if too little oxygen is given, there is a risk of death or brain damage; if there is too much, the babies may develop an eye problem called ROP or blindness. Enter SUPPORT. According to the researchers, their goal was to determine the best oxygen level to get lowest risk of blindness without increased risk of death. This amount had already been narrowed to 85% to 92% oxygen saturation (a measure of the oxygenation of blood) in medical practice; the researchers wanted to find out where within this range is best. Infants in the research were randomly assigned to experimental conditions; in one condition, babies were given enough oxygen to bring the oxygen saturation measure to the lower end of the range (averaging 85%); in the other condition, the higher end (averaging 92%). The researchers found that infants receiving less oxygen did, indeed, have fewer eye problems than did infants given the higher amount, but more of them died.

The critical letter from OHRP stated that the consent forms that the mothers of the babies signed should have clearly stated, but did not, that an increased risk of blindness (for babies in the higher oxygen condition) or death (for babies in the lower oxygen condition) was possible. The ethicist Caplan objected to this. He argued that the researchers were comparing two standard medical practices, since 85% to 92% is the standard range used by doctors. In his view, the current way that doctors decide how much oxygen to use within that range is “a coin flip”; randomly assigning babies to the experimental groups was simply comparing two treatment approaches currently in use to see which one is best and involved no increased risk than the babies would otherwise face. He distinguished this from studies that introduce a new treatment, where informed consent about risks is a different matter. Caplan stated: “I believe that this research is highly ethical” and expressed concern that overly strict rules will hinder needed research. The New England Journal of Medicine editorial also objects to the OHRP letter. The editorial states that the OHRP’s finding that subjects should have been informed of an increased risk of death was based on hindsight. The editorial quotes the researchers, who state that “there was no evidence to suggest an increased risk of death” for infants receiving the lower levels of oxygen before their study was done. The editorial states that OHRP has “cast a pall over the conduct of clinical research” and “strongly disagree[s]” with their letter. SUPPORT, in the editorial’s view is “a model of how to make medical progress.”

What is the controversy? First, with regard to the idea that what was being compared were two versions of standard care, although Caplan does not state this in his article, the OHRP letter specifically addressed this point. In real clinical practice, a range of 85% to 95% exists, but in this study only the extremes were used. As the letter states:

According to the study design, on average, infants assigned to the upper range received more oxygen than average infants receiving standard care, and infants assigned to the lower range received less. Thus the anticipated risks and potential benefits of being in the study were not the same as the risks and potential benefits of receiving standard of care.

Further, in real clinical practice, physicians would be making decisions about where within this range to aim, and how much oxygen a particular infant needed. Caplan assumes that random assignment in the experiment was no different than a physician making a decision. In my view, this is a pretty big assumption. Since the researchers compared infants receiving higher vs. lower levels of oxygen, but did not compare either group with a control group of infants getting real standard care, we do not have evidence whether the babies did better, the same, or worse, than babies given genuine standard care. We know that babies receiving less oxygen in the experiment had fewer eye problems than did babies receiving higher amounts, but we do not have definitive evidence of whether they did better or worse than babies receiving usual care.


May 27th, 2013 by Paula Derry

Articles in the media often report research results with a number, for example the number of hot flashes per day or the severity of menstrual cramps.  However, these are not facts in the way that “man bites dog” would be a fact.  In part, this is because the numbers in research reports often are averages.   Averages are useful summaries, but they also leave out a lot of information.  Take shoe size.  If the average woman’s shoes are size 7, this does not mean that all women are size 7.   It does not mean that a woman whose feet are size 8, 9, or 10 is abnormal or has a problem.   At some point, a very large or small foot could mean that someone has a problem, but knowing where to draw the line requires knowing a lot more than the statistics.  It means knowing something about the biology and biomechanics of feet.  It means knowing about the context—for example, is a woman who wears a size 11 shoe five feet tall?  or seven feet tall?   This is different from a situation where numbers have an absolute meaning.  For example, if my temperature is 102 degrees, then I have a fever, because of the realities of the biology of my body and not because of what most people’s average temperature is.

Image created by Paula Derry

What is an average?  There are a few common ways of computing this. The median is the score for which half of the people being studied have higher scores and half lower. If the scores of all of the people being studied are added together and then divided by the number of people, this gives us the mean.  The standard deviation is a number that indicates variation around the mean.  If whatever is being measured has what is called a “normal distribution” (which is most often assumed) then over 68% of measurements will be within one standard deviation, and over 95% within two standard deviations of the mean.

Take osteoporosis and osteopenia.  Osteoporosis is a bone disease that typically develops in old age in which bone is fragile and more likely to fracture [pdf].  This has been defined as a bone density measurement that is more than 2.5 standard deviations below that of an average 30-year-old woman.   Osteopenia is having bone density that is not thin enough to be osteoporosis, but thinner than “normal,” and is defined as bone density 1-2.5 standard deviations below that of a 30-year-old woman. These definitions are statistical, i.e., different from an average (young) woman. Sometimes women are told that they have bone disease based on these definitions.  With regard to osteopenia, the assumption is that this is an early stage of disease that will get worse over time and become osteoporosis.  Sometimes women with osteopenia are advised to use a medication to prevent the disease progressing.  However, these statistical definitions have been controversial.  For example, other doctors assert that it is normal for bone to thin as women age and that only a small percentage of women with osteopenia go on to get osteoporosis.  Some doctors believe that a diagnosis of osteoporosis itself requires more than low bone density—for example, that a woman has had a bone fracture or that other indications exist.

Or take the number of days in the normal menstrual cycle.  The stereotype is that the average menstrual cycle is 28 days long and that regularly recurring cycles are what is healthy.  A study published in 1967 by Treloar and colleagues presents some of the complexities that this stereotype ignores.   Assuming that there is one average menstrual cycle length for all women leaves out important information about changes that occur over time, across a woman’s adult life.  The average cycle length when a large group of women were studied was indeed 28 to 26 days (median length). However, this was for women aged 20-40. During the first few years after menarche and the last few years before menopause, median cycle length was over 30 days. Even more striking is the amount of variability from one woman to the next, and how this variability changes over time.  Among 20-year-old women, for example, the cycle could be anywhere from 24 to 38 days, or occasionally less or more.  However, the first year that periods began, these differences between women were larger—cycle length was between 18 and 83 days. Variability between women decreased for about eight years, but, as I have said, even when women were most similar (at ages 20-40) there were still big differences among them.  Variability increased again about eight years before menopause; the last year before menopause, women had cycle lengths from 18 to 80 days.  An individual woman’s cycle lengths changed over her life span; further, cycle lengths varied from month to month as well as over a span of years in ways that were very different for different women.

Averages have useful information.  However, it’s always important to know what the numbers mean in order to interpret them.  This is important for knowing what an average means, and it’s always important to remember that an individual’s reality may be very different from the picture derived from finding an average for a large group of people.

Working Mothers

April 29th, 2013 by Paula Derry

“Working Mother and Son” Photo by Russell Chopping // Creative Commons 2.0

Research is often reported as though it is news, as though the most recent article is the best and research that was not published this year is somehow not as interesting or is out-of-date. I recently dug out some articles I wrote about the psychology of working mothers that were based on a study I did in the mid-1980s. I interviewed psychotherapists about how being a mother had affected their professional lives. This study was qualitative research. I offer the results as interesting ideas, not as definitive conclusions.  Some points I think are still interesting:

  1. Overall, about 64% of the 25 mothers I interviewed opted for part-time work; when children were preschoolers, this was about 78%. Psychotherapists, unlike many other women, have the option of working part-time:  part-time jobs, especially for therapists who see clients in private practice, are the same jobs that a full-time worker would have.
  2. I compared the mothers with another group of 19 therapists who did not have children. The non-mothers tended to work full time (about 90%).  However, both groups of women were deeply and apparently equally committed to their jobs.
  3. Many of the mothers (about 60%) felt that work was not as important to them as it would be if they were childless. However, this did not mean that work was unimportant. For most women, it only meant that they now had two strong priorities instead of one.
  4. Almost all of the mothers (88%) felt that having children affected their work as psychotherapists by deepening their empathy, understanding, or emotional knowledge about parents and parenting. This was not simply intellectual, that they knew more facts, although this was also true. It was experiential understanding, a different experience of what facts mean. This was so even though their profession involves helping clients understand their parents or their parenting, and was reported whether they had a child while in graduate school or after they had worked for many years.
  5. One aspect of this increased knowledge was an experience of how passionate an experience mothering is. Another aspect was a less idealized view of both parents and children, and greater tendency to see the experiences of parents and children from their own perspectives. For example, in addition to seeing parents in terms of how their children felt (e.g., that the parent was mean or rejecting), the therapists might perceive more clearly where parents were coming from or that children might misunderstand or be unreasonable.
  6. This greater ability to see the position of both parents and children more clearly is what a psychologist might call psychological individuation. That is, the stereotype is that mothers are or should be all-giving, selfless, thinking only about their children. However, these mothers seemed to grow more realistic, clear about and accepting of who children as well as parents are. As I said in one paper:  “Interconnectedness, or intimacy, requires a sense of oneself and the other as separate but related. (If children really do lack a sense of this separation, that is no reason why their parents, who are adults, should identify with their perspective.)”


Derry, P.S. (1994) Motherhood and the importance of professional identity to psychotherapists. Women & Therapy, 15, 149-163.
Derry, P.S. (1992) Motherhood and the clinician/mother’s view of parent and child. In  J. Chrisler & D. Howard (Eds.), New directions in feminist psychology:  Scholarship/Practice/Research. New York: Springer.

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.

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.”

In conclusion:  It’s always a good idea to approach information with an alert and critical mind, to look for details, to have information about background and context, and it’s always great when you have a resource you trust to help interpret information.

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.