Hormone Therapy & Heart Disease – KEEPS Study Report

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Sometimes it seems the older you get, the more your body becomes like a giant chemistry experiment.  You tweak one thing to feel better, upsetting the apple cart and leading to other issues.  This is never more true than during the menopausal transition, when your hormones careen around the roller coaster track while you hang on for dear life, wondering when the crazy ride will bring you back to the safety of the ride’s platform.

When you’ve hot flashed, suffered from never-ending insomnia and yelled at your kids for the umpteenth time, deciding to give hormone  therapy (HT) a try seems logical and necessary: if for nothing else than to save your sanity.

The problem is—many of you know that heart disease is the number-one killer of women in the U.S. and that might have you wondering what impact HT will have on your own cardiovascular health.

Turns out, it’s a matter of plain old timing.

Put Your Heart Into It

In 2010, the National Institute of Health released results of a 15-year study called the Women’s Health Initiative, which addressed cardiovascular disease, osteoporosis and cancer as it relates to menopausal women on hormone therapy or HT.

That study discovered that replacement hormones might elevate the risks of stroke and heart attack in older women.  However, most of the study’s participants were long past the start of menopause, or their last period.  Why is that important?  Because conversely, women who go on HT within four years after their last period do not generally suffer negative effects on their cardiovascular system, according by Dr. S. Mitchell Harman, director of the Kronos Longevity Research Institute.  He was the lead investigator for the KEEPS (Kronos Early Estrogen Prevention Study) that examined whether starting HT sooner after the onset of menopause reduces the risks of cardiovascular disease and also whether there is a difference between oral and transdermal application of the hormones.

Dr. Harman discovered:

  • Neither transdermal nor oral estrogen treatment significantly accelerates or decelerates rate of change of carotid artery intimal medial thickness (CIMT) in healthy recently menopausal women.
  • Both estrogen treatments have some potentially beneficial effects on markers of CVD risk, but these differ depending on the route of estrogen delivery with improvements in LDL and HDL cholesterol seen with oral and reduced insulin resistance with transdermal.
  • No significant effects were observed on rate of accumulation of coronary artery calcium.
  • Women reported significant relief of vasomotor hot flash symptoms with either form of estrogen

Dr. Harman stated post-study that, “Four years of estrogen treatment in healthy recently menopausal women is unlikely to worsen risk of cardiovascular events and is therefore a relatively safe strategy for relief of menopausal symptoms.”

Different Points of View

Dr. Joseph Raffaele, formerly a clinical assistant professor of medicine at Dartmouth Medical School and co-founder of the PhysioAge Medical Group, believes KEEPS is a good start, but that much more research is in order.  He points out that just a tiny percentage of the women in the study had any significant coronary calcium at all:  85% of the women had a coronary calcium score of  ‘zero.’ The 15% who did have calcium buildup showed an improvement with both the estrogen and estradiol treatments.

“The problem with the WHI study was that its 16,000 subjects were on average too old and too unhealthy to provide meaningful answers to women considering hormone replacement as they enter menopause,” says Dr. Raffaele in a recent blog.

“The problem with KEEPS was the opposite: its subjects were on the whole too young and too healthy (to show significant improvement), especially for a study that only lasted four years.  The researchers should have either used a broader cross-section of subjects or made the study much longer to measure how hormone replacement affects measures of atherosclerosis.”

“KEEPS was not worthless,” says Dr. Raffaele, “The news of the announcement focused on the positives: that hormone replacement safely improves menopausal symptoms including hot flashes and night sweats, depression, diminished libido and bone density.”

“That’s reassuring to women and should help continue to reverse the decade-long misinterpretation of the WHI data that led many physicians to advise against HRT.”

However, Dr. Raffaele says additional research should include a base of at least 5,000 subjects of varying ages and baseline cardiovascular health, and that those women should be followed for 10 years.

This opinion is echoed by Dr. Josh Trutt who says, “In the WHI trial, the women were NOT recently menopausal and were at relatively higher cardiovascular risk: on average 62.5 years old and either overweight or with high blood pressure.  The women in KEEPS are a decade younger and overall healthier, and on estrogen for a shorter time period. It would have taken a very powerful effect to show a benefit in this group.”

Dr. Raffaele points out that just a week after being disappointed by the KEEPS trial report, a new Danish study demonstrated very positive results for recently menopausal women who went on long term HT.  The study appeared in the British Medical Journal.  He further explained that in healthy women (such as KEEPS studied) you need to follow them for a longer period of time to show benefit.  The Danish study followed them for over ten years.  This is key to answering the question KEEPS couldn’t answer:  Does taking HT in early menopause decrease the likelihood of developing cardiovascular disease?  The answer is a resounding ‘yes.’  These Danish women had over a 50 percent reduction in combined heart attacks, heart failure and death.  Remarkably this reduction started to accrue very soon after initiation of therapy. The cardiovascular benefit occurred without any increase in cancers of any type, including breast cancer for which there was a non-significant reduction in comparison to placebo.  Nor was there a significant increase in blood clots or pulmonary emboli.”

However, Dr. Raffaele does point out that the study used 2 mg of oral estradiol, a relatively high dose, and a progestin that is not commonly used in the US for HT.  This study didn’t compare different types of estrogens or routes of delivery: for example, whether transdermal estradiol instead of oral, or micronized progesterone instead of norethisterone acetate, would have had better or worse effects on cardiovascular disease or cancer.

After My Own Heart…

Where does that leave you?  Consider your options; discuss HT with your menopause specialist taking into account your own personal health background.  This will help you and your specialist weigh the risks and benefits to fit your personal needs.

With a family history of heart disease, I went on bioidentical HT early in my menopausal journey. It relieved my brain fog, sleeplessness, hot flashes, vaginal dryness and crashing libido! All the numbers in my Lipid Panel remain in the normal range and my calcium deposit score remains at 0, and my bone mineral density is all in the normal range.  HT gave me my quality of life back and put a smile on my face.  In my “heart”, I know this was the correct course of action for me!

Suffering in Silence is Out!  Reaching Out is In!

After struggling with her own severe menopause symptoms and doing years of research, Ellen resolved to share what she learned from experts and her own trial and error. Her goal was to replace the confusion, embarrassment, and symptoms millions of women go through–before, during, and after menopause–with the medically sound solutions she discovered. Her passion to become a “sister” and confidant to all women fueled Ellen’s first book, Shmirshky: the pursuit of hormone happiness. As a result of the overwhelming response from her burgeoning audiences and followers’ requests for empowering information they could trust, Ellen’s weekly blog, Menopause MondaysTM, was born.

  • Doreen

    Hi Ellen, can you give me an answer to the following question please: does natural progesterone cream help shrink large fibroids or make them grow larger; I am 56 & trying to hang onto my uterus; fibroid 15×10, shrank to 8×5 after 6 GnRHa injections finished at end of March last, but now growing again; have been using natural progesterone cream. I am feeling baffled by the contradictory evidence, & totally baffled by my 56 year old body. I would love your opinion.

    • Ellen Dolgen

      Doreen, I think it is always important to get several opinions when you are experiencing issues such as this. Check out this Dear Ellen for some tips on how to find a menopause specialist. Many of your questions might be addressed here, WomensHealth.gov. Keep me posted! Good Luck!

  • Thanks for the information-rich post. I don’t read enough about menopause in general let alone HRT specifically. It’s great that you keep your finger on the pulse here.

    • Ellen Dolgen

      Glad you found it helpful, Karen!

  • I had 3 grandparents who died of heart attacks in their 60’s, and my father had a catastrophic stroke when he was 71. Whatever the current research is or is not, I won’t take any hormone replacements.

    Research changes every day, and I don’t want to be caught taking something and then hear, “Uh oh. New research say you shouldn’t be taking that!” So I”m going it alone.

    Besides, I am already taking so much medication that I don’t want to take anything else.

    As always great info, Ellen!

    • Ellen Dolgen

      It is always good to go with your gut, Cathy! Thanks for stopping by and sharing your journey.

  • whether to take or not take HRT is such a personal decision. It’s so helpful to have all your research to help inform that decision. I know an individual case does not an argument make, but I started taking HRT early [my menopause symptoms were at the far end of the dreadful curve] and have now been on it for more than 25 years. Feeling great. Living an active life. No signs of heart disease. I wouldn’t give up those little pills for anything.

    • Ellen Dolgen

      Thanks for sharing your story!

  • Thank you so much for this post. I didn’t realize that my insomnia could be linked to my menopause. Thanks for this informative article. I have bookmarked it for future reference.

    • Ellen Dolgen

      I am so happy this was helpful, Pamela!

  • I did HRT for about an year, and they helped. But after a year, I was able to give them up, and manage without. I am at risk for heart disease (Dad and grandparents have it, and I am overweight), so I need to do everything I can…including losing weight (which would solve so many things!)

    • Ellen Dolgen

      I hear ya, Kim.. My father died at 58 of heart disease. His parents, also did not live a long life due to heart disease. So, I went on bioidentical HRT early to help keep my cholesterol in check!

  • I started to have hot ‘feet’ (I’m not kidding) for a full year before my last period. Within 3 months of that date the real heat started and I went in for a little ‘talk’. My gyno (female) said why suffer? We know so much more today. We have changed formula’s, doses, bases, and you will HAVE LESS LONG-TERM SIDE EFFECTS the earlier you start. Then- she recommended bio-identicals! Yippie!!! Low dose transdermal estrogen every day with a organic ( yam based) progesterone cap for two weeks every months. Have you seen my skin? I’m gorgeous! Hahahaaaaaa. Love all you do for all of us Ellen. Thank you for spreading the word.

    • Ellen Dolgen

      Thanks for sharing your story Cheryl! It was great that you went to your menopause specialist for advice and support! Here’s to healthy, happy you!

  • I’ve done HRT since my hysterectomy in 1995. I kept my ovaries. I’ve used Estratest, a combo of estrogen and testosterone. It has worked well for me.

    • Ellen Dolgen

      Thanks for sharing your journey with us, Tam! Sounds like you are taking good care of you!

  • Thanks again for your information. I am not taking anything. I have hot flashes, which increase when I do the things I love, but I like being drug free. Although, my husband thinks I’m losing my mind!

    • Ellen Dolgen

      Janie, as long as you understand your options — go with your gut on what you and your specialist think is best for you.

  • I chose HRT primarily for the “cognitive benefits.” I found that it helped with the “foggy thinking” as you mention. I am so grateful that I did. It has to be an individual decision but for me it was the right one! I have learned that estrogen has a strong impact on memory.

    • Ellen Dolgen

      Thanks for sharing your experience, Ines. I love it when the sisterhood shares – we learn from each other.

  • I have not taken anything and I’m always worried about side effects of medications. Thanks for all the information so everyone can make their own informed decisions about what’s right for them.

    • Ellen Dolgen

      That is the goal, Lois. Every women must make their own INFORMED decision. There is no one-size-fits all solution. I want woman to make those decisions based on facts instead of fear.

  • Catherine Rourke

    As an investigative medical journalist who has been researching women’s health and HRT since 2002, when the Women’s Health Initiative published its first report of the effects of SYNTHETIC hormones on post-menopausal women, I find reports such as this one sadly lacking in all the facts that women need to know to make their own educated decisions to protect their health.

    What this article critically fails to distinguish is the fact that there are TWO different types of hormones: 1. synthetic, or traditional Hormone Replacement Therapy [HRT]; and 2. natural, or Bio-Identical Hormone Replacement Therapy [BHRT]. The WHI clearly found that synthetic or pharmaceutical HRT poses a significant risk of heart attacks in post-menopausal women.

    However, this is NOT the case with BHRT because the molecular structure of these hormones are identical to the same hormones a woman’s body produces naturally. Hence the term Bio-Identical. BHRT is backed by countless scientific studies that indicate no cardiac complications. In fact, BHRT reinforces cardiac health.

    The pharmaceutical industry has jumped on the BHRT bandwagon in recent years and came out with patches like Vivelle and pills like Estrace, but these can pose dangers to heart health because they deliver a surge of hormones that cause a roller coaster effect in the body. That’s why the only proven safe delivery approach is subcutaneous pellet therapy using a precise dose based on an individual patient’s specific needs.

    After spending three years as a medical journalist carefully examining the studies and any risks, I opted for the safest and most effective form of BHRT via the SottoPelle method because it administers an individualized dose of natural hormone based on my body’s specific hormone needs. That was in 2005.

    Back then I was dragging with borderline osteoporosis, a weak heart rate, high cholesterol, fibrocystic breast tissue and could hardly get up in the morning despite a healthy lifestyle. Within 6 months my bone density, cholesterol and heart rate returned around to normal and my breast tissue cleared, again with no lifestyle or diet changes.

    Today — 10 years later at 61 years old — I have the bone density of a 35 year old and a heart that is so strong it blows the doctors away on cardiac stress tests. Ever since I began the SottoPelle BHRT method, I jump up in the morning without any caffeine.

    As a medical journalist, I feel a moral responsibility to examine every study and report the facts for public health and safety. It is a tragedy that these facts remain shrouded and prevent women from leading healthier lives with stronger hearts. The truth about good health is being suppressed by the pharmaceutical industry and this is now a women’s rights issue. I can’t write enough about BHRT and pellet administration in my Truth in Medicine columns, but my glowing health tells all.

    I sincerely recommend that women read in between the lines of these reports that fail to provide the full spectrum of facts and scientific studies. Don’t be fooled by the misinformation that prevails in today’s media. Protect your heart and your health and do your own homework — and go with your own gut.

    • Ellen Dolgen

      Catherine, thank you for taking the time to give us your thoughts and experience. I do not agree that pellets are the only effective form of bioidentical HRT. However, I do agree that it is important for women to go with their gut and get the help that they need and deserve.

  • Great line: “Suffering in Silence is Out! Reaching Out is In!”

    I know that everyone has a different take on HRT, but I appreciate the wealth of information you offer. Thank you!

    • Ellen Dolgen

      Thank you, Esther! Happy you found the info informative.

  • Thank you for pulling in all this great information for review. I haven’t needed anything to date, you’re post gave me a lot to think about.

    • Ellen Dolgen

      So happy to hear that you found the blog helpful!

  • linda

    Love this article Ellen:) got a bit of a giggle when reading about the tweaking effects… that was the hardest in the beginning. After my menapause specialist suggested i do the bio identicle thyroid t4-t3 combo I started to feel the fog lift, the insde furnace turn down and the anxiety flairs calm. The thing that helps me the most is knowing it’s not selfish putting so much attention on taking care of myself. Then I CAN DO SO MUCH MORE FOR OTHERS! Here’s to a smiling HEART♡!

    • Ellen Dolgen

      Go YOU!!! Thanks for sharing this, Linda. It is not selfish to take care of you – it is the most important ingredient for a happy, healthy life!

  • Helen McCauley

    I am 71 years old. I was on HRT for a few years and everything was great. When the Health Initiative for Women came out I was in my early 60’s. It made me nervous, so I stopped taking them. Bam!! My body stated to deteriorate. No energy, body aches, just every thing seemed to go wrong. I would like to know if I am to old to take them again. I would like to enjoy what’s left of my life & not just endure it. Thanks. Helen

    • Ellen Dolgen

      I am so sorry that you do not feel well. Unfortunately, Helen, the new guidelines recommend that women do not go on HRT after the age of 60. Have you had a total physical lately? I would check your thyroid levels and Vit B and D levels. You may need some supplementation to get your energy back. As for the body aches, are you on a statin for cholesterol? If so, please let your doctor know that you are experiencing body aches. Good luck and keep me posted!