Listen as the world's leading menopause expert, Dr. Regine Sitruk-Ware, talks with EmpowHer about this female condition.
Dr. Sitruk-Ware is a reproductive endocrinologist and the executive director of research and development at the Population Council.
Dr. Sitruk-Ware and Todd Hartley:
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Where do the nation’s leading doctors go to share the best health information? The same place you do: EmpowHer.com. From the EmpowHer.com studios, here is Todd Hartley.
Todd Hartley:
Hi, and thank you for joining us at EmpowHer.com where we’re creating the first multimedia medical encyclopedia for women on the Internet. It’s just an amazing groundbreaking tool designed to help generations of women advocate for their health.
Now EmpowHer has sent me all over America to interview the top doctors so you can have access to leading medical experts who are doing work, really on the cutting edge, and today is no different. On the phone right now we’ve got the world’s leading menopause expert.
Now did you know that 65 million women in the United States over the age of 45 suffer from menopause? Now think about that for a moment, 65 million American women, and that’s why Dr. Regine Sitruk-Ware, a reproductive endocrinologist and the Executive Director of Research and Development at the Population Council, is with us right now. Their website is popcouncil.org. Dr. Sitruk-Ware, we are honored to have you join us.
Dr. Sitruk-Ware:
Thank you, thank you for calling.
Todd Hartley:
Oh, it really is our honor. Can we start at the very beginning? Exactly what is menopause?
Dr. Sitruk-Ware:
Okay, now the definition of menopause is, in fact, it means that the menses stop, but in fact it corresponds to the loss of the main components in the ovaries that produce estrogen during the reproductive life. So when menopause is concerned, which means there is no more production of estrogen by the ovary, the woman suffers from the sudden deprivation of the main hormone that maintains most of the function in her body.
And of course, the levels of estrogen drop suddenly from something around 100 to below 15 in terms of the unit when we measure estradiols. So there is a sort of a big gap, big drop, and this creates symptoms, and with time, after many years with a situation of a low-estrogen level, although the sudden hot flashes that occur only in the first few months when the estrogen level drops, after several years there are some other consequences of low estrogen, like loss of bone mass and brittle bone or increase in cardiovascular risk because of vessel resistance, atrophy of the vaginal walls and therefore dyspareunia, which is in fact pain during intercourse, and all of these symptoms may occur at different levels according to the woman herself.
Some women would not feel as bad as others because their levels of estrogen do not drop as much as their counterparts. I mean, it varies from subject to subject, but what I am telling you and describing to you is for the majority of the women.
Todd Hartley:
Yeah, you just described a very good overview on what menopause is and then gave me the symptoms that many women experience. Let’s talk about treatment for a moment, like what’s the difference between hormone replacement therapy and hormone therapy?
Dr. Sitruk-Ware:
Well, as an endocrinologist, I would use rather the term "hormonal replacement therapy" because the woman does not have anymore the estrogen hormone and she needs replacement. She needs that we give it back as we would give back a thyroid hormone if her thyroid doesn’t function anymore.
And in other places people prefer to use the term “hormone therapy” because they consider that menopause is physiological, and therefore, if we give a treatment it is sort of additional treatment, it’s not a replacement. That’s a school of thinking of various experts, but most of the endocrinologists would rather speak of replacement because this hormone, although at a physiological time of life is so important and has so much benefits to the woman’s health and due to the increase in life expectancy, we cannot really not replace it when women can tolerate of course exogenous replacement, because if this phenomenon happens when they are 50, they will have to live 40 more years without any estrogen.
Todd Hartley:
Dr. Sitruk-Ware, if a woman is experiencing the symptoms of menopause that you mentioned earlier in this interview, what type of doctor is she supposed to seek out? For example, is her regular female doctor skilled enough to know what’s going on with her menopause? Does she need to go see an endocrinologist? What do you normally tell women?
Dr. Sitruk-Ware:
Well in theory, I mean the first general practitioner or doctor that would have been taking care of the patient is obviously the first contact, but that doctor may not feel comfortable or knowledgeable enough in the field, and they refer the patient to an endocrinologist or what we call now menopausologist.
There are credentials for the menopause and especially the North American Menopause Society has created a mini-diploma to give the possibility to many doctors who are Ob/Gyns or endocrinologists an additional training and qualification for the menopause itself, because the menopause management is really complex and multifactorial. It implies not only endocrinology know-how or gynecology knowledge but it’s rheumatology, cardiology, and neurology aspects of the menopause, and therefore having a know-how in all these areas is very important to give good care.
Todd Hartley:
Yeah, it sounds like it’s an essential element to have all those different fields inside your area of expertise. I know that it’s quite common at EmpowHer.com that women are asking for help. They say, “Oh you know, I was experiencing all the symptoms of menopause. I went to my doctor who claimed to be an expert, and four years later on, a variety of different things, I feel worse than I did before.” Do you hear that commonly?
Dr. Sitruk-Ware:
When I was seeing patients, yes. I mean, there were patients coming to me and having had some negative experience, and I think the confusions have increased recently after the Women’s Health Initiative publication because it has created so much inconsistent messages and different interpretations that the doctors who are not specializing in this area, would be totally confused.
So, the women themselves even more, and I think this is what we hope and what the menopause societies are trying to do in various countries, is to try to really bring the key messages clear enough so all doctors would be well-informed and could treat the patients.
Todd Hartley:
Let’s talk about the Women’s Health Initiative then. It seems like the initiative indicated a lot of negative things about hormone therapy, at least on the surface level, but, once you start to dig into it deeper, there seems to be a whole different can of worms that really just got opened by the Women’s Health Initiative. What do you tell people when they ask you about the effectiveness of that study and really where their faith should lie?
Dr. Sitruk-Ware:
The Women’s Health Initiative was really a fantastic study in its purpose and it’s a colossal investment and having involved so many centers, so many subjects who have accepted to participate in a very complex and long-term study, was really a challenge and a very good achievement.
Now of course there are always weaknesses, and people criticize the weaknesses, and mostly the people have over-interpreted or misinterpreted some of the results. Overall, the first message was negative because they had a rate of the various adverse events, and then, when they considered that they had reached too much negative outcome with the treatment compared to the women who were receiving placebo, then the Safety Monitoring Board had decided to stop, and then it was publicized largely as everything was negative.
And what I consider was the mistake and the wrong message was that it gave this first message as negative without having the sub-analysis, that you just mentioned after digging more into the data. It was premature to really announce it was all negative, and, it was extended to all therapies of all kinds.
While the study was on a certain population with a certain therapy, it could not be really extended to all, and the other weakness that of course was due to the design of the study itself. To get the study going on without having in fact the people know which treatment they had, the active treatment or the placebo treatment, they had to get women who would not have too much symptoms, and women who had in fact bleeding were recognized as receiving the hormone as compared to no bleeding.
So, they had one group where they could use estrogen alone without progestin because they had no uterus, so it was not the population at a younger age, and then they had a population of women with a mean age which was 63 and above. And so, the majority of women were far into their menopause when they joined into the study.
While in theory, the doctor sees the patient as soon as they get symptoms at the beginning of this stage, the change in their reproductive life, and they come into the menopause and get symptoms. So, the population of younger women who were usually the women who receive treatment was only 10% in the Women’s Health Initiative, and the majority were older, and there is a good group of women who were above 75.
When no one would think of giving this hormone therapy, then it is a therapy rather than a replacement. So, the first thing that they observed of course was influence by this age group. When women had been many years without treatment and suddenly receiving hormones, then they had more negative outcomes than benefits.
And the sub-analysis that I mentioned was when they considered this younger age group, women between 50 and 60-65, during the first 10 years of treatment, the women got the benefit in terms of cardiovascular risk, and this was consistent with all the previous academiological studies, which indeed considered that population, that age group of 50 to 65.
So, this was one aspect. The second aspect was about breast cancer, which was considered really as the main reason for stopping the study. But even in the first paper, people would have paid attention to the sub-analysis of women who have never received treatment before they got into the study. These women were 12,000 instead of the 16,000 of the total number in the study.
In this subgroup of women who were in fact virgin, without any hormone therapy, there was no increase in breast cancer risk. There was no difference between the active and the placebo, and it’s only in the 4000 women who had been 5 or 10 years before treated with other hormone, got the wash-out, which means for three months they did not receive any treatments before they got into the study and received the therapy.
Those women had already accumulated some risks, and then on the top of that they received five more years of treatment and there, the risk increase. So when they mixed up the whole group, all the population of those who had already received hormones and those who have not, the overall increase was at 1.25-1.3, which means 30% increase.
But in fact, the purpose of the study was to see that women who had never received treatment versus placebo and then you see what is the risk brought by the treatment, and in that subgroup of treatment for five years did not induce any change.
So there was a lot of controversies and people arguing that they would have not read carefully the results, and the risk of breast cancer would have varied according to the past history, and women who had never received hormones before could receive hormones safely, with no risk for their breasts for five years.
And those women, who are young, the moment they start to have symptoms and can get five and even up to seven years, can even benefit from the cardiovascular point of view and not increase their breast cancer risk.
So what we have seen with that, the treatment was refused to women without any nuance or a difference and really checking what was their past history and their specific profile, and the main goal of menopause treatments in what we can say in all of the meetings dealing with this menopause matter, is that the treatment has to be tailored to the woman.
Now of course, the large studies need to be done. They need to have good scientific evidence, but at the end of the day what applies for a group does not apply necessarily to each individual, so we have to tailor treatment to the personal profile of each woman.
Todd Hartley:
What I like about that is you used the word "tailored." You used it twice, and to me that means if you get a suit or you’ve got a nice outfit, you’re going to get it tailored specifically to your body, and very much similar to your hormone therapy, it would be something, it’s not a "one size fits all." That’s a really good reminder for women out there.
Bioidentical hormone replacement therapy is something that gets described a lot, sometimes accurately, inaccurately. How do you define bioidentical hormone replacement therapy?
Dr. Sitruk-Ware:
The term itself, "bioidentical hormone,” has been criticized and banned in fact by the Endocrine Society and by the American College of Ob/Gyn because it was misused and was considering any kind of man-made hormone that would be similar to the physiological hormone, and what we prefer to use as the term would be the physiological hormone.
Estradiol, which is produced by the ovary, and progesterone, which is also produced by the ovary when the woman still ovulates, are the physiological hormones. Now, these two hormones have to be synthesized to be put into a tablet or to be put into a vaginal ring or into a gel or in a patch, to in fact mimic the physiological hormone.
But, there are other compounds that are mimicking but are not necessarily exactly estradiol or exactly progesterone, are still called bioidentical and not necessarily reflect the physiological component. In any case, it’s always, it has to be synthesized. It has to be manufactured by a chemist to take the structure of this hormone which is in the body and make it the same into a tablet or into whatever formulation.
So, what we would say would be that replacing estradiol and replacing progesterone and during the physiological life, during the reproductive years of the woman, would be the best option because then we would give them back the natural hormone, physiological natural hormone. But the term has been used in different cases and was not necessarily approved.
Todd Hartley: Well, she is Dr. Regine Sitruk-Ware. She is a reproductive endocrinologist and the Executive Director of Research and Development at the Population Council, popcouncil.org is her website. Doctor, I remember, this conversation reminds me of the first time that I heard the term "menopause." I was sitting on the couch with my grandmother and out of the blue, my grandmother turned to me and said, so I was probably 12, and she turned to me and said, “So Todd, have you started puberty?”
And I was scared, right? I didn’t know what to say so I said, “I don’t know, have you?” And she said, “Are you kidding? I am already into menopause,” and that was my first time I ever really had any, my first awareness of even the word.
So we’ve been talking today about menopause and the symptoms. I’d like to talk with you about perimenopause, and really what is it and is it something that should scare women? Is it an opportunity for them to learn more about their body so they could be preventive and understand risk factors down the road? What exactly is perimenopause?
Dr. Sitruk-Ware:
There have been different groups trying to define carefully the term "perimenopause" and when this stage would start in the life, in the reproductive life of the woman. In fact, it’s the years around the menopause and mostly the years before the ovary stops completely to produce estradiol and progesterone.
So what happens is that four years, sometimes even six or eight years before the final, the day that there would be no more estrogen produced by the ovary, the ovary starts to function a little bit irregularly, and the command which comes from the brain, from the pituitary gland, is also modified.
So what happens is that the cycles become irregular. The women does not have always an ovulation each cycle. She may have a shorter or a longer cycle and therefore the balance between her two key hormones, estradiol and progesterone, is insufficient, inadequate.
So they may have already hot flashes and period where the secretion of estrogen is too low or have other symptoms due to over secretion of estrogen. The function of the pituitary gland, as I said, would be modified by the signals sent by the ovary. The ovaries send a signal, there is less follicle, the small bodies containing ovum, and the woman cannot ovulate regularly, but the signal says to the pituitary, "There is a lack here," so the pituitary secretes more of some hormone that pushes the maximum of hormones that can be produced in the ovaries, and so suddenly the woman is in the stage where she has too much estrogen.
So she has breast tenderness, bloating, irritability, anxiety, and then periods when everything would stop temporarily, and then she has depressive mood, hot flashes stopping, and this is a period called perimenopause, but we cannot really… there are several options which are proposed at this stage.
Some people prefer to use a replacement of progesterone itself or use progestin or use a pill, contraceptive pill, because the women still ovulates from time-to-time, so the odd twist can hit the period of their life between 45 and 52, they may not necessarily want another baby.
And another option was proposed to place an intrauterine system that contains a small dose of a progestin, and this is a system that can protect the internal layer of the uterus because the internal layer of the uterus, during the situation of the hormone, may be blocked too much and create what is called hyperplasia, which can lead to endometrial cancer.
So, there is need for a treatment to correct the balance between the hormone present and desired ovulation and undesired pregnancy, and when the woman starts to have the specific symptoms related really to the lack of estrogen, then be able to stop the treatment for the estrogen and a progestin if they have a uterus, but carefully follow the subject to be sure that we are not continuing to treat her while her ovaries suddenly have another burst of production of an estrogen until we get to the stage of menopause itself where all the follicles have disappeared and there is no more production of estrogen at all.
I hope I was clear; it was long.
Todd Hartley:
Yeah, no, it was very clear and informative. It painted a very good picture. Dr. Regine Sitruk-Ware, is there a symptom or a condition that makes hormone therapy inadvisable?
Dr. Sitruk-Ware:
Yes, I mean, there are contraindications to the use of hormone, and one of the main condition is breast cancer. So if a woman has a high risk of breast cancer or because of genetic necessity or strong family history or she has herself had a breast cancer, usually the treatment requires that we block the estrogen, and then some other treatments can be used like what is called "selective estrogen." We have the modulators which will be more antagonistic on the estrogen in the breast and still protect for the other organs like the bone or the uterus.
The other condition would be women who have venous thrombosis and several, or severe cardiovascular disease. Then, the treatment is negative, and what the Women’s Health Initiative has really shown is that women who would have had already some changes in their vessels and they were treated for cardiovascular disease, those women may be accident. Those women got with the treatment a worsening of their condition.
So, breast cancer, history of cardiovascular disease, history of severe thromboembolism, are all conditions that would contraindicate the use of estrogen, synthetic estrogen and progestin, and therefore there are some other therapies that could be used under these conditions to treat the most prominent symptoms of the women and help them to get relief.
Todd Hartley:
That’s valuable information. You don’t really even hear that that often. Recently a female visitor seeking help at EmpowHer.com asked the following question, Dr. Sitruk-Ware, she asks, “If a woman takes hormones to get rid of hot flashes or whatever her symptom might be, will she just have to go through those symptoms later on in life when she gets off of those hormones?”
Dr. Sitruk-Ware:
Yes, unfortunately each time, there is a sort of thermostat in the brain and activity to the estrogen center that will register that they were hormones and then suddenly the hormones drop. Now, the symptoms may be less each time because usually the replacement therapy or the estrogen therapy that is given is at very low doses, or the treatment can be decreased by weaning progressively, because of taping the treatment and under this condition there is no big drop, and so there is no recurrence of symptoms.
The symptoms get expressed when there is a real big decrease between the ejaculating levels of estrogen, and suddenly they drop and there is almost nothing. While there is a progressive decline, the symptoms do not mature as strong and progressively disappear.
Todd Hartley:
Well, she is Dr. Regine Sitruk-Ware. She is a reproductive endocrinologist and the Executive Director of Research and Development at the Population Council. The website is popcouncil.org. Dr. Sitruk-Ware, quite an honor for EmpowHer to have you on our program.
Dr. Sitruk-Ware:
Thank you very much for this opportunity and I hope it will help women get treatments and the Population Council tries to develop treatment to help women all over the world, and we also have a new system to deliver more safely some hormone that could help and that is our objective.
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