Latest / Clearly Hormonal / Ep 03: Breaking Down the WHI Hormone Therapy Trials

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Ep 03: Breaking Down the WHI Hormone Therapy Trials · Clearly Hormonal

• 0:06
  Dr. Komal Patil-Sisodia: Welcome to the Reset Recharge podcast with your host, Dr.
• 0:10
  Dr. Komal Patil-Sisodia: Komal Bhatia Sisodia, a board certified endocrinologist, internist, and obesity medicine specialist.
• 0:16
  Dr. Komal Patil-Sisodia: This podcast is focused on empowering women's health and aims to help you reset your understanding of your metabolic health.
• 0:23
  Dr. Komal Patil-Sisodia: And recharge the conversations you are having with your healthcare providers.
• 0:27
  Dr. Komal Patil-Sisodia: While I am a physician, this podcast is purely for educational purposes.
• 0:31
  Dr. Komal Patil-Sisodia: No individualized medical advice is being given on this podcast.
• 0:34
  Dr. Komal Patil-Sisodia: If you do find information that is helpful, please discuss it with your healthcare provider at your next visit.
• 0:43
  Dr. Komal Patil-Sisodia: Hi, everyone.
• 0:44
  Dr. Komal Patil-Sisodia: Welcome back to Reset Recharge.
• 0:47
  Dr. Komal Patil-Sisodia: I want to start off this episode with a story about a patient I saw a few months into my first job.
• 0:56
  Dr. Komal Patil-Sisodia: My medical assistant walked into my office and told me that The patient that was here to see me was in her early 80s and was coming in to see me for weight gain, fatigue, and concerns about her hormones.
• 1:09
  Dr. Komal Patil-Sisodia: According to my medical assistant, the patient was pretty upset.
• 1:15
  Dr. Komal Patil-Sisodia: I took a deep breath and got myself ready.
• 1:17
  Dr. Komal Patil-Sisodia: And when I walked into the room, the first thing she said to me was, You need to restart my hormones.
• 1:25
  Dr. Komal Patil-Sisodia: I tried to introduce myself, but she kept going.
• 1:28
  Dr. Komal Patil-Sisodia: She said, I feel terrible.
• 1:30
  Dr. Komal Patil-Sisodia: My new primary care doctor made me stop my hormones two years ago, and now I'm falling apart.
• 1:36
  Dr. Komal Patil-Sisodia: My face is sagging.
• 1:37
  Dr. Komal Patil-Sisodia: I have a tire around my middle.
• 1:40
  Dr. Komal Patil-Sisodia: My hair is falling out and everything hurts.
• 1:42
  Dr. Komal Patil-Sisodia: You have to do something.
• 1:47
  Dr. Komal Patil-Sisodia: I remember sitting in the room and feeling so conflicted.
• 1:51
  Dr. Komal Patil-Sisodia: At 82, she looked like she was about 65 and was describing her life with hormones as being great.
• 2:00
  Dr. Komal Patil-Sisodia: I was at a complete loss for what to do.
• 2:03
  Dr. Komal Patil-Sisodia: I kept thinking back to my conversation with my program director and then thinking about what all my other colleagues were doing.
• 2:10
  Dr. Komal Patil-Sisodia: Everyone was pulling their patients off of hormones because of the study.
• 2:15
  Dr. Komal Patil-Sisodia: Everything about this woman's story was conflicting with what we were all being told to do by professional medical societies.
• 2:23
  Dr. Komal Patil-Sisodia: I heard her out and did my best to empathize.
• 2:28
  Dr. Komal Patil-Sisodia: And then I told her there was nothing I could do for her since she'd been off of hormones for a few years, and the recommendation was to stop after five years.
• 2:38
  Dr. Komal Patil-Sisodia: The patient asked me to reconsider.
• 2:40
  Dr. Komal Patil-Sisodia: And she even told me that she was willing to accept any risk of whatever came with restarting the hormones.
• 2:45
  Dr. Komal Patil-Sisodia: Cancer, heart disease, blood clots, stroke.
• 2:48
  Dr. Komal Patil-Sisodia: She would take it.
• 2:50
  Dr. Komal Patil-Sisodia: She just wanted to get back to feeling better again.
• 2:55
  Dr. Komal Patil-Sisodia: I gently told her again that I couldn't write the prescription for her.
• 3:00
  Dr. Komal Patil-Sisodia: I had no context to how she was feeling because I was, I think in my late twenties or early thirties at the time.
• 3:07
  Dr. Komal Patil-Sisodia: And like every new doctor that was.
• 3:09
  Dr. Komal Patil-Sisodia: It's just going into practice.
• 3:11
  Dr. Komal Patil-Sisodia: I was afraid of getting sued if something bad happened.
• 3:16
  Dr. Komal Patil-Sisodia: She never came back to see me.
• 3:19
  Dr. Komal Patil-Sisodia: And I don't blame her at all.
• 3:21
  Dr. Komal Patil-Sisodia: I don't think I'd go back to see me.
• 3:25
  Dr. Komal Patil-Sisodia: So I often look back on that patient visit with a lot of regret.
• 3:30
  Dr. Komal Patil-Sisodia: I wish I knew then what I know now.
• 3:34
  Dr. Komal Patil-Sisodia: The Women's Health Initiative Hormone Therapy Trial was a terrible study.
• 3:38
  Dr. Komal Patil-Sisodia: And it kills me to think how many women have been under medicalized for the last two decades.
• 3:45
  Dr. Komal Patil-Sisodia: In the last episode, we talked about how our bodies start to change in our mid 30s to 40s, our hormones are declining, and the risk of metabolic disease is climbing.
• 3:56
  Dr. Komal Patil-Sisodia: It would make sense that if we were going to intervene with hormone replacement, it would be to help decrease disease and improve quality of life.
• 4:07
  Dr. Komal Patil-Sisodia: and that we would do it earlier.
• 4:10
  Dr. Komal Patil-Sisodia: The Women's Health Initiative Hormone Therapy Trial wanted to study whether hormone replacement therapy could prevent cardiovascular disease in postmenopausal women.
• 4:20
  Dr. Komal Patil-Sisodia: So they enrolled women between the ages of 50 to 79 with an average age of 63.
• 4:27
  Dr. Komal Patil-Sisodia: 3.
• 4:28
  Dr. Komal Patil-Sisodia: Let's think about that for a second.
• 4:31
  Dr. Komal Patil-Sisodia: If our hormones start declining in our 40s, And bottom out somewhere in our fifties, that's at least one decade too late, if not more, depending on when your periods stop.
• 4:42
  Dr. Komal Patil-Sisodia: And on that first point alone, the study is flawed because while they wanted to look at postmenopausal women, to me, it would make more sense to do it earlier.
• 4:54
  Dr. Komal Patil-Sisodia: Additionally, the women were put on high dose oral hormones, meaning they were taking them by mouth.
• 5:01
  Dr. Komal Patil-Sisodia: In the women who still had their uteruses and had not undergone a hysterectomy, they were started on a combination of estrogen and progesterone because you need progesterone to protect the lining of the uterus.
• 5:13
  Dr. Komal Patil-Sisodia: If they had undergone a hysterectomy, they were put on estrogen alone.
• 5:17
  Dr. Komal Patil-Sisodia: The hormones that they used were also not bioidentical, which means identical to what our bodies produce.
• 5:24
  Dr. Komal Patil-Sisodia: They used something called conjugated equine estrogens and medroxyprogesterone, which we now know are not the best formulations.
• 5:32
  Dr. Komal Patil-Sisodia: At the time the study was done, we also didn't know that oral estrogen compared to transdermal or what we call a topical patch, um, had a higher risk of blood clots and that the synthetic progestins or progesterones that are not bioidentical are associated with an increased risk of breast cancer when taken by mouth.
• 5:56
  Dr. Komal Patil-Sisodia: When the study was first analyzed, they looked at all of the ages lumped together and saw an increased risk of coronary heart disease, invasive breast cancer, but only in the group of women who were given estrogen and progesterone.
• 6:11
  Dr. Komal Patil-Sisodia: On that basis alone, the researchers made the decision to stop the trial.
• 6:16
  Dr. Komal Patil-Sisodia: The wild thing is that The women who were in the estrogen only arm did not have the same increased risk.
• 6:23
  Dr. Komal Patil-Sisodia: And that was apparent when they stopped the study.
• 6:25
  Dr. Komal Patil-Sisodia: They only saw it in the estrogen and progesterone arms.
• 6:30
  Dr. Komal Patil-Sisodia: Interestingly, in that initial study, and every study that's done, every scientific paper has this, they have a section called limitations.
• 6:38
  Dr. Komal Patil-Sisodia: And limitations talks about what may have been flawed about their study.
• 6:42
  Dr. Komal Patil-Sisodia: And they have a sentence that said, hormone preparations like transdermal estradiol and progesterone may be a better regimen, but need to be tested.
• 6:52
  Dr. Komal Patil-Sisodia: None of this was talked about early on when the study came out.
• 6:56
  Dr. Komal Patil-Sisodia: Instead, the news headlines in 2002 said inflammatory things like, Study is halted over rise seen in cancer risk.
• 7:07
  Dr. Komal Patil-Sisodia: Expert panel backs HRT cancer risk.
• 7:10
  Dr. Komal Patil-Sisodia: And my personal favorite, HRT linked to cancer and stroke.
• 7:14
  Dr. Komal Patil-Sisodia: Doctors demand restrictions.
• 7:18
  Dr. Komal Patil-Sisodia: Holy moly, what would, I mean, what would you do if you saw a headline like that about a drug you were taking?
• 7:24
  Dr. Komal Patil-Sisodia: I would be running to my doctor's office, because even if I was feeling good on it, with everything I would be seeing in the headlines, I wouldn't want to have heart disease or cancer and I would ask my doctor to take me off of it.
• 7:36
  Dr. Komal Patil-Sisodia: And I think that's actually exactly what transpired.
• 7:39
  Dr. Komal Patil-Sisodia: Either doctors got scared and were pulling women off of hormones, or women got terrified and went to their doctors and begged to be taken off of hormones, and here we are today.
• 7:51
  Dr. Komal Patil-Sisodia: It wasn't until a few years later that the researchers actually subdivided the women in the study into age categories.
• 8:00
  Dr. Komal Patil-Sisodia: That's called a stratified analysis when they look at, um, at the different, uh, when they divide out the population and they look at it again.
• 8:07
  Dr. Komal Patil-Sisodia: And so they divvied the women up into age group 50 to 59, 60 to 69, and 70 to 79.
• 8:14
  Dr. Komal Patil-Sisodia: And what they found was that the younger women did better with the hormones than the older women.
• 8:21
  Dr. Komal Patil-Sisodia: And there were less bad effects in the women who were taking estrogen only, which we kind of knew at the first study, but was not really talked about.
• 8:31
  Dr. Komal Patil-Sisodia: This analysis showed that coronary heart disease and breast cancer risk was actually not only there in, was not there in the women who were taking estrogen.
• 8:40
  Dr. Komal Patil-Sisodia: Especially in the younger women, but in the older women age 70 to 79, they saw an increased risk of heart disease in the women who were taking only estrogen.
• 8:50
  Dr. Komal Patil-Sisodia: But to me, that kind of makes sense, right?
• 8:52
  Dr. Komal Patil-Sisodia: If you were not given hormones until you hit 70, but your period stopped somewhere in your 40s and 50s, isn't it kind of reasonable to think that you may have developed heart disease along the way?
• 9:06
  Dr. Komal Patil-Sisodia: And then I added hormones on top of it and then drawn a false correlation or a false association with the estrogen causing the heart disease.
• 9:15
  Dr. Komal Patil-Sisodia: The study also looked at what they call self reported outcomes where they sent questionnaires out to the women who were still in the study and were reliant on sending them back.
• 9:25
  Dr. Komal Patil-Sisodia: I don't want to go through these outcomes line by line, mostly because it will put everyone to sleep.
• 9:29
  Dr. Komal Patil-Sisodia: And that's not the point of this podcast.
• 9:32
  Dr. Komal Patil-Sisodia: So instead, I have put together some charts to summarize the findings from the study that you can look at on your own time.
• 9:39
  Dr. Komal Patil-Sisodia: They'll be included on the show notes on my website, along with a link to the original study if you should feel inclined to read it.
• 9:49
  Dr. Komal Patil-Sisodia: So, by the time this stratified analysis came out, the damage was done.
• 9:55
  Dr. Komal Patil-Sisodia: The media frenzy around the initial findings of the study pushed healthcare providers to take women off of hormones, and then that fear of hormones that has developed has done lasting damage to women's health and has set us back for decades.
• 10:11
  Dr. Komal Patil-Sisodia: So interestingly, just before I recorded this podcast on May 1st of this year, the researchers from the original study released a review of the Women's Health Initiative in JAMA, which is the Journal of the American Medical Association, to reiterate and clarify their conclusions.
• 10:30
  Dr. Komal Patil-Sisodia: Their statement reads for postmenopausal women, the Women's Health Initiative clinical trials do not support hormone therapy to prevent cardiovascular disease, dementia, or other chronic diseases.
• 10:41
  Dr. Komal Patil-Sisodia: Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause without contraindications who are interested in taking hormone therapy.
• 10:53
  Dr. Komal Patil-Sisodia: That's literally the same conclusion they drew from the study 20 years ago, but stated in a much less scary way.
• 11:00
  Dr. Komal Patil-Sisodia: And the headlines, this time around, are also the opposite of what was initially reported.
• 11:07
  Dr. Komal Patil-Sisodia: The Washington Post headline, which I think was the first one that was published, says, No need to fear menopause hormone drugs, finds major women's health study.
• 11:17
  Dr. Komal Patil-Sisodia: And PBS had another one that says, Hormone replacement, safe and effective menopause treatment, study finds.
• 11:25
  Dr. Komal Patil-Sisodia: The power of the media is wild.
• 11:29
  Dr. Komal Patil-Sisodia: It's literally the same study.
• 11:31
  Dr. Komal Patil-Sisodia: Just two different time periods and headlines that are catchy for the time.
• 11:42
  Dr. Komal Patil-Sisodia: What drives me crazy is that there is still not any conversation around the limitations of the study in a meaningful way.
• 11:52
  Dr. Komal Patil-Sisodia: So this review that was just published also has a limitation section, and they had one sentence in there.
• 11:58
  Dr. Komal Patil-Sisodia: It's one sentence that basically says the same thing as it did in the SA in the first study that the Women's Health Initiative, hormone Therapy trials tested.
• 12:08
  Dr. Komal Patil-Sisodia: Estrogen plus progesterone and estrogen alone, using the most common hormone therapy formulations at the start of the study, but other hormone therapy formulations or routes of delivery may have yielded different results.
• 12:21
  Dr. Komal Patil-Sisodia: I paraphrased that a little bit, but you get my drift.
• 12:25
  Dr. Komal Patil-Sisodia: That's it.
• 12:25
  Dr. Komal Patil-Sisodia: Just one sentence talking about how limited that study was.
• 12:31
  Dr. Komal Patil-Sisodia: So what's the lesson here?
• 12:33
  Dr. Komal Patil-Sisodia: For me, it's that we need more studies at the start of perimenopause and all the way through it, not after we've gone through menopause and our periods have stopped.
• 12:46
  Dr. Komal Patil-Sisodia: We're giving out birth control without thinking about it to help regulate periods or prevent pregnancy or take care of acne.
• 12:54
  Dr. Komal Patil-Sisodia: Birth control pills have the same hormones that we give in HRT, just at different doses.
• 12:59
  Dr. Komal Patil-Sisodia: I would love to study whether women who are in their 40s would benefit from getting low dose hormone replacement or even being on birth control, low dose birth control through their 40s until they hit menopause and then be switched over to HRT.
• 13:17
  Dr. Komal Patil-Sisodia: Does that prevent metabolic disease?
• 13:20
  Dr. Komal Patil-Sisodia: Does it prevent all of the risk factors for metabolic disease?
• 13:25
  Dr. Komal Patil-Sisodia: Does it prevent the symptoms?
• 13:26
  Dr. Komal Patil-Sisodia: Does it improve quality of life?
• 13:28
  Dr. Komal Patil-Sisodia: There's so many things that we can track.
• 13:31
  Dr. Komal Patil-Sisodia: But that study is not going to be done anytime soon.
• 13:33
  Dr. Komal Patil-Sisodia: And in the meantime, many of us are going to go through perimenopause transition without a clear guideline on what to do.
• 13:43
  Dr. Komal Patil-Sisodia: This is where I think that talking to your doctor about any symptoms that are coming out, any new medical conditions that you're developing, and advocating for yourself becomes crucial.
• 13:55
  Dr. Komal Patil-Sisodia: If you are not getting traction on getting answers, get yourself to a certified menopause specialist.
• 14:00
  Dr. Komal Patil-Sisodia: These wonderful practitioners exist.
• 14:05
  Dr. Komal Patil-Sisodia: If you go to the North American Menopause Society website, which is menopause.
• 14:10
  Dr. Komal Patil-Sisodia: org, there is a search tool that you can use to find a certified menopause specialist in your area.
• 14:18
  Dr. Komal Patil-Sisodia: And I will link that in the show notes as well.
• 14:23
  Dr. Komal Patil-Sisodia: So today's key take home points.
• 14:26
  Dr. Komal Patil-Sisodia: Number one, Women's Health Initiative Hormone Therapy trial was a bad study.
• 14:32
  Dr. Komal Patil-Sisodia: Number two, the study conclusions were misconstrued slash wrong depending on who you ask and want to talk about it with.
• 14:40
  Dr. Komal Patil-Sisodia: And three, we need to start advocating for studies that look at perimenopause transition and whether we can impact how we're feeling sooner and whether we can prevent diseases from coming on if we start acting sooner.
• 14:58
  Dr. Komal Patil-Sisodia: Remember, we are our own best advocates.
• 15:02
  Dr. Komal Patil-Sisodia: Nobody has been advocating for us for a while, and we need to step up and do it.
• 15:07
  Dr. Komal Patil-Sisodia: Thank you for joining me today.
• 15:08
  Dr. Komal Patil-Sisodia: Feel free to reach out through my website or social media with any topics that you want to see discussed on future episodes.
• 15:15
  Dr. Komal Patil-Sisodia: I'll see you next time.