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(CLOCK TICKING)
(MUSIC)
(Dr. Peter Salgo)
Welcome to Second Opinion, where each week we solve a real medical mystery. When we close this file a half an hour from now, you'll not only know the outcome of this week's case, you'll be better able to take charge of your own healthcare and doctors will be able to listen to patients more effectively. I'm your host, Dr. Peter Salgo. You've already met our special guests joining our primary care physician, Dr. Lou Papa. Lou, good to see you again.
(Dr. Lou Papa)
Hi, Peter.
(Peter)
No one on this team has seen this case, so we're going to get right to work. Let me tell you a little bit about Sue. Sue is fifty-eight years old. She's in her PCP's office, and Sue is unhappy. She feels like she's getting conflicting information - that's her phrase - from her doctor, from the media. She's having major trust issues. For the last seven years, Sue has been struggling, she says, with menopausal symptoms. In her early fifties, they prescribed conjugated estrogen for peri-menopausal symptoms, and it really worked for her. Her symptoms went away; hot flashes disappeared and other annoying symptoms of the menopause went away. She took the hormones for a few years and it's not really clear from the dates in the chart exactly how long. She felt great until one day her doctor said to her, "Sue," he said, "you got to stop taking the hormones," and when she asked why he said that there was something called the Women's Health Initiative and that the findings there said don't take this stuff. Lou, did that ever happen to you in your office?
(Lou)
Oh, it's still happening now. I know exactly what you're talking about. It's very true. I mean, that - the issue about hormone replacement therapy has kind of ridden this undulating wave in terms of taking it/not taking it. So it's a real thing.
(Peter)
But here are these women feeling great.
(Lou)
Right.
(Peter)
They come to their office one day or they watch the television and, bang, they can't take it. Tell me about the Women's Health Initiative, what you were looking for, and then what happened.
(Dr. Jacques Rossouw)
Yes. So, first of all, let's be clear that the Women's Health Initiative did not test the effect of hormones in women like Sue, who was using it for the treatment of hot flashes and night sweats around the age of menopause. What we were testing is whether hormone therapy would prevent coronary heart disease. Hormone therapy was being used for treatment of hot flashes, and I'd swear it's for prevention of osteoporosis and then, in the late '80's, early '90's, for the prevention of coronary hearth disease. You know, learned bodies, some of which I served on, recommended it for the prevention of coronary heart disease because it lowers blood cholesterol. So you'd think it would be good.
(Peter)
So, you're into this study. A few years into this study you stop the study. What happened?
(Dr. Jacques Rossouw)
Well, we found that estrogen with progesterone, in this case - we stopped that trial in 2002 because it did not prevent heart disease. In fact, in the first few years, it increased the risk of heart disease, and it also increased the risk of stroke and of blood clots and of breast cancer. It did have -
(Peter)
Other than that it was a great idea?
(Jacques)
Well, it did prevent fractures, and there was some suggestion it lowered colorectal cancer. And in those women, incidentally, who had hot flashes and night sweats, it did treat those, too.
(Dr. Peter Salgo)
But you went on for two more years, right, using estrogen alone?
(Jacques)
We - the second trial used estrogen alone. That's in women who've had a hysterectomy. They don't need the progesterone. That estrogen only also did not prevent heart disease, also increased the risk of stroke and of blood clots.
(Peter)
Now, Lisa, you were taking - by the way, we should point out for our regular viewers, you are a doctor and you play one on TV, but for the purposes of this discussion, you're here because you're someone who used these drugs.
(Lisa)
That's right. I pretend to be one, but they tell me I am, since I graduated from medical school. And I -
(Peter)
We can vouch for that.
(Dr. Lisa Harris)
fit very much into that category with Sue. I was diagnosed with diabetes and high blood pressure, high cholesterol only about four or five years ago and was on oral contraceptives, and the first thing my doctor said to me was, "Well, you know, we have this Women's Health Initiative. We probably don't need to have you on high doses of estrogen. We need to think about getting you off of oral contraceptives and finding another thing to do." And I said I'd rather have the heart attack than not take the birth control pills, and along that line my periods just started becoming very short while on oral contraceptives and that - and I was very young. I was only forty-two years old. My gynecologist didn't believe that I was in menopause because I was so young, as she put it. So they made me wait a year of hot flashes, of night sweats, of wanting to just about kill people, and when you're in a room with a patient and you have a - it's not just a little bit of warmth; you feel like there's a fire inside of you and you begin to just burn up and you - you know, starting to sweat in front of a patient makes them really wonder what's going on, and to wanting to disrobe in front of a patient because you're so hot.
(Jacques)
Yeah, "What's wrong with you?"
(Lisa)
You know, "Excuse me, I have to run out and get some ice and take care of it," and it was like, "You can't take hormone replacement because of your risk factors." And we finally did settle on a hormone replacement therapy that works.
(Peter)
So how many people like Lisa, like Sue were out there on hormone replacement therapy, perfectly happy, if you will, because the symptoms of the menopause were going away, and content they were probably doing something beneficial for their heart, for their bones only to suddenly be told, "Whoops, you're actually hurting yourself. Stop it now"? Do we know the numbers, anybody? Is it sufficient to say it's a lot?
(Jacques)
There were - yeah, it sure was a lot. It was something like twelve million people that were taking it in the early '90's, and that's dropped by more than half since then.
(Peter)
Patricia, the cardiologists were allover this.
(Dr. Patricia Fitzpatrick)
Well, I think that's true. I think if you look at the history of cardiology societies and what recommendations they made over time, it got stronger and stronger in terms of the wording of, yes, this is good for your heart, based, though, solely on observational trials before studies like the Women's Health Initiative was undertaken.
(Dr. Peter Salgo)
Let me ask you something. Women went through menopause long before we had exogenous hormones to make the symptoms go away. Are women today with access to these hormones - let me ask you a loaded question - overreacting to menopause symptoms? Lou, I normally ask you this and get you into trouble.
(Lou)
I'm keeping my mouth shut.
(Peter)
I'm asking you.
(Brent)
After listening to that graphic description from Lisa, I can tell you that women who had bad hot flashes want estrogen replacement therapy. They want it and they don't want to go off of it, and if you take them off of it and they get bad symptoms, they may want to go back on.
(Peter)
I can give you some more data, because Sue followed her doctor's advice and stopped taking the hormones. What do you think happened? I'll tell you. She became really concerned. By the way, her symptoms came back and she started watching television, she started reading the newspaper, she became really concerned about her own health, and at that point, she started to blame her doctor for putting her in danger, in the first place, by giving her this hormone replacement therapy. Is her anger rational, Lou?
(Lou)
Her anger is justified. I don't think it's necessarily rational. I mean -
(Peter)
What's the difference?
(Lou)
Well, justified in the sense that she was put on therapy that potentially could put her at harm. Rational in the sense that, as a doctor, based on the information that was available at the time, there's no way you could've known that.
(Lisa)
And, see, I'm not really - there's a couple things I want to address. One that the symptoms - that we want to relegate the symptoms to just a histrionic woman that's feeling a little bit warm. That is not what we're talking about.
(Peter)
Mind you, I moved away from you -
(Lisa)
Yes, you did.
(Peter)
Before you gave this answer.
(Lisa)
That's not what we're talking about for women who really require HRT, and in Sue's case, it's really not clear what else - what were her other risk factors? Why was she taking the hormone replacement therapy? Was it just for menopausal symptoms, or were they really trying to prevent heart disease? And that's the conversation that you have to have with your doctor, and that's the conversation certainly that I had, you know, what do we need, how do we balance these risk factors, what do we need to do so that you can function, because we're talking about functionality.
(Dr. Peter Salgo)
I could tell you what the word was in the chart. Sue said, "My doctor has been irresponsible in giving me estrogen in the first place." Lisa? Anybody?
(Kathy)
Well, I had a lot of - I have talked to lots of women around the country with heart disease, obviously, and a lot of them are very angry about, you know, the study and how, in some ways, they felt that they were kind of misled by their physician, that they personally didn't understand the risks they were taking by taking these medications, and that they really felt that they were unjustly put in a position of risk.
(Dr. Lou Papa)
The problem is is that retrospectoscope has got 20/20 vision, and at that time - let's put it this way. If that study showed that it did reduce the risk of hearth disease and stroke, the doctors would look like geniuses.
(Jacques)
Of course. Yes. Now, that's an excellent point, and that's the reason why the results of the study got so much publicity, because it went against very widely and deeply held belief system that it would.
(Peter)
Let's be very clear. You're a cardiologist. And before the Women's Health Initiative data came out, which questioned the use of these hormone replacement therapies, was there data in the literature, research in the literature that suggested that at least as far as cardiac risk was concerned hormone replacement therapy was a good idea?
(Patricia)
Yes. There were observational studies that looked at life spans of women that were taking hormone therapy, and those studies suggested that you could improve your risk of heart disease by taking hormone therapy.
(Peter)
Now, observational studies, how does that differ from what you guys did?
(Jacques)
There's a great deal of difference. The observational studies look at the health effects or the health consequences in women who would choose to take hormone therapy versus those who choose not to take hormone therapy.
(Peter)
Your study, if I may put words in your mouth, was better controlled than the observational studies? It was -
(Jacques)
Yeah.
(Peter)
It was clearer?
(Jacques)
It's what's called a randomized controlled clinical trial, and in an RCT the participants are randomly allocated to either the active treatment or the placebo group. And what that does is it equalizes the two groups, so that there are on average no difference between them. If then at the end of the study you find a difference between the active and the placebo group, it's due to the treatment. It's not due to any characteristics of the participants who take hormone therapy.
(Peter)
I think where we are right now in this discussion is what's a doctor to do? You had information, albeit not as good as perhaps the huge Women's Health Initiative study that said this was a good thing to do. You come along and say maybe it's not such a good thing to do. You're getting whipsawed, aren't you?
(Patricia)
It was very difficult to try to teach women the difference between prevention and treatment, and I think that's the key here. The Women's Health Initiative was looking at could this medication actually prevent disease?
(Dr. Peter Salgo)
Heart disease.
(Patricia)
Heart disease specifically, and the women that were taken out of the study were women just like Lisa who were so symptomatic that there's no way that they would come off hormone therapy and be randomized to a placebo. That's a very different situation.
(Peter)
So, I'm going to pause here for a minute, but let's just stop and sum up where we are right now. Research brings out new and sometimes confusing information all the time. That's why it's called research. It can be frustrating for patients. I can assure you it's frustrating for doctors. You need to stay in touch with your doctor when you're on any therapy to make sure that your care is as up to date as possible, and sometimes up to date means you've got to change what you're doing. Is that fair?
(Group)
Mm-hmm.
(Kathy Kastan)
Well, I'm a little confused. So you're saying that the Women's Health Initiative is not - it doesn't apply to women like Lisa?
(Peter)
Well, what I heard - correct me if I'm wrong - is that women like Lisa were carved out from the study.
(Patricia)
They weren't in the trial. I think where it's helpful when you're trying to decide what to do for somebody like Lisa is understanding your choices and what risks you're going to accept, so that you can get treated for the symptoms that are so important to you. So knowing the risks are very important.
(Peter)
Let me tell you what Sue did. Sue hadn't had a period in three years. She struggled with menopause. She has frequent hot flashes. She's not sleeping. She's feeling depressed. She actually went on anti-depressant medication to try to control the depression, but that hasn't been completely successful, so she went back to her doctor's office and she says, "Please help me." At that point, what do you think her doctor did?
(Jacques)
Put her back on it.
(Peter)
Yes, he did. He put her back on HRT. Now, is this a good idea? She's fifty-eight years old, by the way.
(Lou)
I think what this does is it brings it back into the realm where it's - that second bang for the buck is taken out of that picture. So that hope of that it's benefiting you cardiovascularly is taken out of the picture, and you have to really assess the risk of that treatment, just like you do with anything else.
(Peter)
Well, let me go around the panel. Would you have put her back on HRT? You're our cardiologist here.
(Dr. Patricia Fitzpatrick)
Probably, but I would make very clear what her risk factors for developing heart disease were and make sure that she controlled those, blood pressure, diabetes, cholesterol.
(Dr. Peter Salgo)
Would you have done that?
(Dr. Brent DuBeshter)
Because of these studies and the controversies regarding them, we've changed what we do a little bit. I don't use long-term estrogen replacement therapy anymore, but for women that have severe symptoms, the conversation is focused mainly on, you know, the cardiovascular side of this. But there are benefits to therapy and short-term use has not been shown to be a big problem, so I think it's okay to use them short-term, not long-term -
(Lisa)
And I think one of the things that we -
(Brent)
and to pay attention to the risk factors.
(Dr. Lisa Harris)
that we need to point out, too, is that the study was looking at estrogile plus progesterone, correct?
(Jacques)
And it was conjugated equine estrogen plus medroxyprogesterone.
Dr. Harris
Progesterone.
(Jacques)
Yeah.
(Lisa)
And so one of the options is that that's not the only type of HRT that you can use.
(Jacques)
Her doctor sounds like he's going to or she's going to prescribe hormone therapy and -
(Peter)
I can tell you that her doctor did.
(Jacques)
I would not put this lady on any form of hormone therapy. I would do everything possible to treat her symptoms through other means.
(Peter)
He would've started her.
(Lisa)
...risk of breast cancer.
(Peter)
You already said you would. Would you have started her back up?
(Lou)
Right. I think part of Brent's hesitance also is you don't have the complete picture, either. You don't have that cardiac risk factor.
(Kathy)
That's important.
(Lou)
And you don't get an idea of, like, "I'm going to kill people, if I don't get these hot flashes treated." That kind of - that weighs into that - it's the same type of thing of, you know, if you've got terrible osteoarthritis of the hip. Sometimes people die from surgery. That's a quality of life decision you're making there, but you're taking on that risk because the benefit's going to help your quality of life. That's kind of the discussion you have to have with these patients.
(Peter)
What are the risks to women on HRT?
(Brent)
There's this - I think a twenty-five percent increase in breast cancer risk and there was an increase in stroke and heart attacks, but one of the things that I wanted to get at, as the practitioner, was to try to balance those risks, which we do all the time. And what we're doing in our practice now is I just tell patients I wouldn't recommend using them for more than five years, and so that -
(Peter)
So five years is what you would consider a brief period of time?
(Brent)
Yes.
(Dr. Peter Salgo)
Because what you hear is you use them briefly.
(Lou)
At a lower - at-
(Peter)
At a low dose, but five years is brief, ten years is long?
(Brent)
We use the lowest dose as possible to control the symptoms because we're, in general, just doing this in patients that have severe symptoms.
(Peter)
All right. Let me get -
(Kathy)
Well, I'm a little confused or, I guess, a little scared as a perimenopausal woman in her late forties only because I know women out there are still very confused by all these studies and I know that you should individualize treatment for sure and you should definitely talk to your physician or your healthcare provider about these issues. But eighty percent of women between the ages of forty and sixty have one or more risk factors for heart disease. So, if we know more of what these risk factors are and they come to you and you know that that's a tradeoff, it just scares me, just the whole idea that, you know, okay, well, we'll put them on for five years and just - you know, it's like a -
(Lou)
And that happens -
(Kathy)
crapshoot.
(Dr. Lou Papa)
with patients. I will tell them. I say, "I want you to assess these symptoms, and you need to be able to be aware of the fact that if you get a blood clot, if you develop breast cancer, if you develop a heart attack or a stroke, that -
(Kathy)
"So, sorry."
(Lou)
you're good with that in some respects, you know, that you
(Peter)
"You're good with that."
(Lou)
felt that that risk was worth it." I mean, that's the reality of it. You have kind of like
(Peter)
What about
(Lou) what Lisa said.
(Kathy)
What are other options?
(Peter)
What about the risk for endometrial cancer?
(Dr. Brent DuBeshter)
Estrogen alone should not be used in a woman who has a uterus, because there's clear and convincing evidence over many, many years that if you have a uterus, chronic exposure to estrogen will definitely increase your risk of uterine cancer.
(Dr. Peter Salgo)
And statistically, since women have stopped using HRT as much as they used to use it, hasn't the breast cancer rate gone down in that group?
(Patricia)
Yes.
(Jacques)
Yes.
(Peter)
So let me ask this question, which is - this has taken on a life of its own, the Women's Health Initiative. It's got a - it's got - there's a political aspect to this, and it's wrapped up in the women's movement, it's wrapped up in a lot of very highly volatile political positions. It's challenging the Women's Health Initiative in its absolute form, don't take these hormones, has been seen as akin to being anti-women, exposing women to increased danger and death. Where did all that come from?
(Lou)
I think a lot of it came from the fact that something like this was a long time coming, that a lot of women health issues was kind of bundled in with men's health issues, and that it wasn't a serious avenue of research. And that was one of the big - biggest studies that were done on women's health, and it was a blockbuster. I mean
(Kathy Kastan)
Well, and the other problem is women weren't included in clinical trials until the mid-'80's, so here we go again, and yet, "Here, trial and error, we're going to give you this estrogen progestin and, you know, go for it. Let's see what happens."
(Lou)
Exactly.
(Patricia)
Correct. Then the
(Kathy)
And voila, we end up with these problems.
(Patricia)
And the concept that heart disease is even a problem for women is a relatively new concept, and it has taken a long time for women to start to appreciate that. They still think breast cancer is their biggest health risk.
(Peter)
What are the recommendations right now for HRT? Who's a good candidate for it and for how long?
(Jacques)
I think it's okay to use it for women with bad hot flashes and night sweats, short-term, starting at the age of perimenopause, four to five years stop, and most women actually only need it for a year or two because these symptoms are usually self-limiting. There's an indication still for osteoporosis prevention, particularly in younger women, and at age sixty you can switch to something else, like a bisphosphonate, and there also is the issue of vaginal dryness and disparunia, that is painful intercourse. Topical local estrogen is very effective for that. That's the - that's when it's okay to use hormone therapy, and that is basically it. And then the flip side is you don't use it long-term to prevent chronic disease. That - and that - that's the part that the Women's Health Initiative specifically addressed.
(Peter)
What about cancer risk, Brent, do you agree with all this so far?
(Brent)
Well -
(Peter)
How does cancer risk fold into that?
(Brent)
What Jack said is pretty much what we do. I deal with a lot of patients that undergo surgical menopause often times before age fifty when they would've ordinarily become menopausal, and they have severe symptoms. I recommend and our group recommends replacement until the age of - that you would've undergone menopause. After that, I limit people to five years.
(Peter)
Lisa, how long have you been on HRT?
(Lisa)
It's been about two years now.
(Peter)
Two years?
(Lisa)
Mm-hmm.
(Dr. Peter Salgo)
So you've got two to three more years.
(Lisa)
Something like that.
(Peter)
Are you planning on stopping it at that time?
(Dr. Lisa Harris)
Well -
(Peter)
Why do I detect a maybe?
(Lisa)
For me it's a maybe, but when I go to my physician's office I'm a patient and I don't - I'm not a doctor when I enter into the office. So the discussion will center on what are the risks and the benefits, and, you know, I'm sure she'll recommend that we take some time off and see what happens.
(Peter)
Let's review Sue for just a second. Sue is fifty-eight, three years out from her last period, no history of heart disease or cancer. Now we have a history in the chart, which we were lacking before. Her primary complaints are hot flashes, poor sleep, and depression. Is she a good candidate for replacement therapy or just hormone therapy, if you would like to use your nomenclature, and is it safe for Sue to use -
(Jacques)
The odds are that it's not safe based on what we know, because she'll probably increase her risk of future stroke, heart attack, blood clots, breast cancer.
(Peter)
We know from Sue's history that she had depressive symptoms. She was on medication, though we don't know which medication. It might've been an SSRI for all we know, and it didn't help.
(Lisa)
Right.
(Peter)
Now, depression is of and by itself a serious medical disease. Does hormone therapy or hormone replacement therapy help with the depression?
(Jacques)
No.
(Peter)
You're saying no.
(Jacques)
No.
(Dr. Peter Salgo)
There's no evidence that says it does.
(Jacques)
No, it has been looked at. The evidence is that it doesn't help.
(Peter)
No help at all?
(Patricia)
Well, I guess it - all I would say to add to that is if she's partially depressed because she's not sleeping well at night and she's getting hot flashes, her mood might actually be a little bit better. I'm not trying to trivialize depression, but it might actually help her if her symptoms of menopause are helped.
(Peter)
All right. Let's sum up where we are now. I want to keep going, but we've again covered a lot of ground over here. Hormone replacement therapy is a viable option for some women. As with any other therapy, I think we can agree that there are pluses and minus. There is controversy around HRT, I think that's obvious, and all those TV reports are not about you specifically; they're about the population in general, they're statistical. If you want to find out what you need to do, then you really need to talk with your doctor about your specific risks and your specific benefits. You are not a statistic. Let me tell you about Sue. Sue began taking a low dose of hormone therapy. It worked in the sense that she's feeling better, her symptoms have gone. It doesn't say if her mood is better, but since - it says here she feels great. Great, I'm going to assume, is a lump sum for everything. She goes back to her doctor every six months and she gets, quote, checked out, unquote, and I'm assuming she's getting checked out for cardiac problems, cancer problems however her doctor chooses to do this, but at the back of her mind Sue's worried because she hasn't forgotten the results of the Women's Health Initiative. And she's feeling okay, but she's worried. Is that worry well-justified?
(Dr. Lou Papa)
Absolutely.
(Lisa)
And Sue needs to practice preventive medicine for herself. So, in my own case, given that I have all these other risk factors, I make sure that I exercise regularly, that I eat healthy, that I try to sleep, so that all of my numbers are really picture perfect so that we're trying to reduce that risk of complication as much as we can.
(Jacques)
Yeah, that's -
(Peter)
Is there evidence to show that what she's doing is going to reduce her risk?
(Jacques)
Yeah, there is some evidence on that. If you think of preventing heart disease, your number one priority is to take care of your risk factors. Identify and treat your risk factors.
(Peter)
Let me just ask. We're in the age of empowerment of women, which is a good thing, and you've made a choice, which is - and, in fact, as a physician, you've made a - I would assume - a very intelligent and well-researched choice. "I know the risks." You give me this look, but "I know the risks," I'm sure you said, "I'm willing to accept them because I want the benefit." Isn't every choice you make a balance between risk and benefit?
(Lou)
Absolutely.
(Lisa)
Absolutely.
(Peter)
And is the message here that nothing is that absolute?
(Lou)
Nothing is that absolute.
(Peter)
You know, this has been a great, great discussion, but we're out of time, and I want to thank all of you for being here. Lisa, I know it's hard sometimes for a doctor to shed the M.D. and be the patient, and it couldn't have been easy for you to share all this with us, so thank you so much for joining us.
(Dr. Lisa Harris)
Thank you.
(Dr. Peter Salgo)
With that, what I want to do is sum up some of the things we've discussed. Research brings out new and sometimes confusing information all the time. It can be frustrating for patients. I assure you it's frustrating for doctors, who have to give advice. You need to stay in touch with your doctor to make sure that your care is as up to date with the current research as possible. Hormone replacement therapy is a viable option for some women, but as with any other therapy, there are pluses and minuses. There is controversy around HRT, and all those TV reports are not about you. This is really important; they are about groups of people, not you individually. You need to talk with your doctor about your specific risks and benefits. It's very important you remember that. And our final message is this; taking charge of your health means being informed and having quality communication with your doctor. I'm Dr. Peter Salgo, and I'll see you next time for another Second Opinion.
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