Suzanne Somers touts them in her bestselling book, Ageless: The Naked Truth about Bioidentical Hormones. Oprah promotes their use. On the other hand, the Harvard Medical School, the North American Menopause Society, and the Endocrine Society take a more cautionary position toward compounded bioidentical hormones. And I find that many of my patients are just confused.
So what are bioidentical hormones and what’s all the controversy surrounding them?
We’ve written a lot on Middlesexmd.com about the importance of estrogen to vaginal health and sexual function. We’ve also discussed various options for replacing estrogen and enhancing vaginal comfort. And we explored the latest thinking about hormone replacement therapy (HRT).
In a nutshell, estrogen is critical to sexual comfort and function, and that’s the hormone we lose during menopause. Most therapies revolve around replacing estrogen to treat menopausal symptoms.
For many years, Premarin was the estrogen replacement of choice. This is a synthetic estrogen made from the urine of pregnant mares, which, according to the Harvard Women’s Health Watch, “contains a mix of estrogens (some unique to horses), steroids, and various other substances.”
Bioidentical hormones, on the other hand, are defined by the Endocrine Society as “compounds that have exactly the same chemical and molecular structure as hormones that are produced in the human body.” Bioidentical hormones are usually extracted from plant sources.
Pharmaceutical companies manufacture many brands of bioidentical estrogens, such as Vivelle, Elestrin, Divigel, Evamist and one brand of bioidentical progesterone (Prometrium). These are FDA-approved bioidentical hormones. About 95 percent of my patients are on these FDA-approved bioidentical hormones.
All hormones, whether they are synthetic or bioidentical, are labeled with the black-box warnings mandated since the massive Women’s Health Initiative study linked slightly higher rates of breast cancer, blood clots, and heart disease to hormone replacement therapy.
So far, so good.
Confusion enters in when bioidentical hormones are custom-compounded by pharmacies. Sometimes there are good reasons for a doctor to prescribe a custom-compounded hormone, if a patient is allergic to some agent in the FDA-approved hormones, for example, or if her dosage can be lower than those produced by pharmaceutical companies.
But hormones made by custom compounders aren’t subject to FDA oversight, nor must they adhere to FDA-approved processes. These custom hormones don’t come with black-box warnings because they don’t fall under the FDA umbrella.
In actual practice, there may not be that much difference between custom hormones and FDA-approved hormones. According to the Harvard Women’s Health Watch, in a 2001 random test of 37 hormone products from 12 compounding pharmacies, almost one-quarter (24 percent) were less potent than prescribed, while 2 percent of FDA-approved products were less potent.
The other problem with custom compounds is cost. Health insurance usually doesn’t cover them, so the regimen gets expensive very quickly.
While custom compounds may be a helpful option for some women, the controversy surrounds the claims about them made by celebrities like Suzanne Somers and even by some clinicians.
In the introduction to her book, Somers writes, “This new approach to health [bioidentical hormone replacement therapy] gives you back your lean body, shining hair, and thick skin, provided you are eating correctly and exercising in moderation. This new medicine allows your brain to work perfectly and offers the greatest defense against cancer, heart attack, and Alzheimer’s disease. Don’t you want that?”
Well, who wouldn’t? But like most claims that sounds too good to be true, so is this one.
The truth is that bioidentical compounds, no matter how “natural and safe” they may sound, are still drugs. There’s no scientific evidence that their effect is any different than synthetic hormones. Also, because hormonal levels vary from day to day, even from hour to hour, attempting to customize hormonal treatments is tricky business. “There’s no stable ‘normal’ value at all for salivary or blood levels of these hormones or levels that correlate with symptoms,” says the Harvard Women’s Health Watch.
The current medical advice is to take the lowest possible dosage of any hormone—synthetic or bioidentical—for the shortest period of time to alleviate menopausal symptoms. There is, unfortunately, no way to turn back the clock—”natural” or otherwise. In the meantime, the hormones that work for a woman can significantly improve her quality of life.
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Interested in what other Vibrant Nation members have to say about bioidentical hormone therapy? Download the FREE Vibrant Nation report, Considering Bioidentical Hormone Therapy? What Every Woman Over 50 Should Know
Janice,
Thanks. I like myself the way I am, bags and all. I have no intention of having face work. I do exercises for my face and they actually help.
Thank you for posting this. For a short time I was using bioidentical hormones because of my ridiculously heavy periods (I have a small fibroid). I stopped because it was becoming very costly and because I would prefer to do something more natural.
what did you use instead of the bih?
Hi greenlady,
I’ve been mostly trying out organic unsulphured blackstrap molasses and oil pulling. Unfortunately, I haven’t been getting the positive results I was hoping for. What I’ve really noticed is how much stress effects things. I hear diet plays a huge part, along with stress.
Here’s a site that offers all kinds of alternative suggestions: http://www.earthclinic.com/
Thanks for the link I would also like to see Magnolias response to Terry.
As usual, I say it all depends on the study you want to quote and the “expert” you want to trust above others.
There *is* a lot of confusion for women regarding bioidentical hormones and their safety. I think it is directly related to physicians taking a stand against them and communicating what you have communicated here.
I do not take issue with the fact that bioidentical hormones are also synthesized in a lab……because, obviously, they are. But, I don’t know that calling them a “drug” in the same sense that synthetic hormones are considered drugs is a fair statement.
I think women need to become proactive and do the reading themselves as much as possible. At least then, we can make an informed decision about which poison we want to take and why.
Personally, I use testosterone pellets. I have no issues with vaginal dryness or libido. Trust me on that one.
Magnolia
Hello Magnolia – How are the testosterone pellets working for you? I mentioned testosterone to my doctor due to muscle loss, and he was not very open to the idea. I have heard from other women that they do help. Where are you getting yours?
Terri
Hi Terri,
There is a physician here in the Dayton, OH area who is doing a lot of research on testosterone pellets.
I see her for mine. She is very cautious because she is also a surgeon who treats women with breast cancer.
I know this issue is confusing for so many women. I strongly believe we need to be proactive with our health, whether it is bioidentical hormones or anything else.
The medical community is doing the best they can. But, they are fallible human beings just like we are. They make mistakes. They draw erroneous conclusions and are limited by the research that has already been done.
Life is full of risk. Every time we trust the voice of our physician we are taking a risk. Every time we take a Bayer aspirin or a Tylenol or Advil we are taking a risk.
So, what can we do? Again, I say, stay pro-active, educate yourself, then make the decision that you think is best for your health.
Magnolia
I had tried biodentical hormones for a full year and suffered terribly. I put on five pounds of water weight, felt lethargic, migraine headaches and leg cramps. I am a personal trainer and eat healthy and exercise regularly. I felt no advantages to taking these hormones either mentally or physically. I was constantly retested (saliva test – horrible) and readjusted through my Gyno. I was 62 years old and menopausal. Oh! How can I forget the mood swings – forgetaboutit! If nature wanted us to have our hormones than I believe that it would have been done that way. Thank you for your honesty in posting this information; but, it sure is way overdue.
I cringe when I hear Suzanne Somers talk like she is an expert in hormones. Bio identical hormones are hormones and yes, if someone is allergic to some of the ingredients of the other kind, ok, buy bio – but if you are at risk of breast cancer because of family background, estrogen is estrogen and you should stay away. I took hormones from age 51 to 65 – the lowest dosage, and during the last 7-8 years, only every few days – enough to help me have decent sleep while I was still employed and really needed my sleep. I felt great, my skin was glowing, no osteoporosis, etc. Now, about 6 months after stopping, my skin is still glowing, I feel great and I guess it’s because I eat super healthy, I sleep enough, exercise and keep my brain active.
A lot of confusion comes from lumping Progesterin and Estrogen into the same discussion. Progesterin is an OTC hormone that is useful for a lot of women. It is completely safe.
The issue is Estrogen. Two issues in fact. Issue One: don’t use it on its own – doing so can kill you. It has to be balanced with Progresterin. Second issue: do you use the kind that comes from horses and is not bio-identical or do you use a bio-identical alternative? Constant confusing discussion about it. Why?
Logic says bio-identical has to be better than non. However the big money is in non-bio-identical since bio-identical cannot be patented and thereby sold for huge sums of money. So of course big pharma is going to argue against the cheap bio-identical option.
Forget our health for a minute and even the fact that premarin and other equinine derived estrgeon sources have contributed to the death of women as proven in US courts.
Think about the horses. Premain and Prempro use estrogen from PREgent Mares. Mares are used a baby foal making machines in order to extrat their urine to feed this industry. They are not treating kindly nor are their foals. This is a cruel callous industry.
Women should be saying NO to Premarin and Prempro because even if you don’t believe it kills women, it certainly kills horses.
Great info, Dr. DePree, and I wish more docs would speak out against celebrities giving inaccurate medical advice. Your post also makes me glad I “winged it” through menopause, and rejected HRT.
Look up Tracy Ullmans spoof of Suzanne Sommers on Youtube..hilarious! Have yourself a good laugh..I’m personally happy without the hormonal stuff of my youth.
I took them for about 12 years after a complete hys/ov. at 40. My own personal opinion is that our bodies are MEANT to slow down hormone production at a certain age. All this celebrity “take this or that to be forever young” just seems to be counterproductive to the life cycle. And DANGEROUS. I listen to no celebrity or anyone else who promises eternal youth. With all the hubub going around about them, I asked my dr. his opinion about my taking them again at 57, and–as I have no symptomatic reasons why I should–his advice was no.. My own instinct told me that, as well. Thanks for the article.
I agree with Hot Flash. It is the progesterone that is usually low or not there. And I feel there is a big difference between what the drug companies produce (Premerin, Prempro) and what your reputable (been doing it for years) compounding pharmacy will make just for your body from plants. She is right, do your research and find out what works best for your body. We are all different, have different issues, and respond differently. By the way, Dr. Christiane Northrup says, ” hormones can be balanced by diet and exercise” which is what I do. Best to all of you finding what your body needs. By the way, The North American Menopause Society used to receive funding from one of the major pharmaceutical companies and probably still does.
I want to make a correction in my post. I will quote Dr Northrup as saying,
“Most menopausal symptoms including weight gain, all chronic diseases can be managed with diet and exercises alone.”
This is from her cd, “Menopause and Beyond”
Thanks!
Sorry to hear bio identicals aren’t working for some of you. I have been using them for 3 years and will continue to do so. I had lost all sensation during intimacy. I was fatigued all the time. Iwas depressed and over the top irritable. I could not think clearly. I gained 30 pounds.I simply felt miserable all the time. I tried homeopathic remedies, synthetic hormones, and just suffering through it. Thank goodness I learned about bio identical hormones! I fell like they literally saved my life! All I cn say is I will continue to use them as long as I can. I feel healthy again!
Thanks for the post…but I have to say…I would not trust the FDA with anything…they are in bed with the Pharma companies and do not have the best for women or any living creature in their best interest.
I would almost always go for something outside their jurisdiction.
There was an earlier post regarding the horses’ urine used. Below is some info from Wikipedia. Although horses are prettier than cows, the argument could be made that they are “livestock” like cows or pigs and therefore slaughter is not an obscenity, unless you don’t want to use cows, pigs, chickens, bison, et al. for anything.
The downsizing of the industry led to another change. With a lesser quantity of urine needed for the production of Premarin, the ranchers involved in the industry were no longer limited to using only draft horses. More of a focus on breeding saleable foals has been seen, with an emphasis on selecting good quality stallions to sire the foals. Crosses now popular within the industry may include such breeds as Quarter Horses, Thoroughbreds, Hanoverians, Paints, and other such breeds, in addition to the more traditionally-used draft breeds. The ranchers rely on selling foals as much as they rely upon the urine collected from the pregnant mares. Many of these farms utilize websites and forms of promotion identical to non-Premarin related horse breeders, and, in nearly all ways, are indistinguishable from the average breeder of equines.
Currently, those in favor of the industry claim that standards on farms are strict and meticulous records must be kept, and that all ranchers must follow the “Recommended Code of Practice for the Care and Handling of Horses in PMU Operations” in order to keep their contract. They further state that ranchers are regularly inspected to ensure they are following these codes in order to ascertain well-maintained animals and facilities.
Please be careful with any type of hormone replacement. I took Premarin for 12 years and am now in my 5th year post Breast Cancer diagnosis. Sometimes it isn’t good to mess with Mother Nature.
One thing I learned recently is that the story is a bit different for those of us who have had hysterectomy. My doctor told me the the ovaries continue making estrogen after menopause – just a greatly reduced amount. She said that women who have had hysterectomies therefore need to take HRT for the rest of their life, not just during menopause.
I have tried going the bioidentical route and although I suffered no side effects I also noticed no difference at all between that and Estradiol. I went back to the Estradiol because it was covered by my insurance. I use a wild yam cream to supplement progesterin because I do notice symptoms if I don’t supplement that.
I’m personally tired of people who are former celebrities who attempt to extend their shelf life by writting books and selling products like supplements or perfume..I have a friend who is on bioidenticals and loves it..she tries to sell it to everyone else. I had a hard time going through the pause, but now despite a few chin whiskers I’m fine. I really don’t want to feel like I did when I was young..because this ole body just isn’t up to it..I’m married to a man eight years my junior and he likes me just like I am..we’ve been married 35 years. The only true expert for my body is the one that made it and me.
I know we all like to quote “Mother Nature” as the final authority on health and wellness.
But, if losing hormones and then suffering from the ill effects due to lack of proper balance is “Mother Nature’s” wisdom on health.
Then, I say somebody needs to bitch slap “Mother Nature”
Whether we are talking bioidentical hormones or big pharma synthetics, or any other medications, supplements, etc., that we take for our health……you are taking a risk. Period.
I rather like the advice of my physician who is continuing to do research on testosterone pellets for perimenopausal and menopausal women…….she understands the issues with the Suzanne Somers mentality. And she also understands the biased interests of the pharmaceutical companies…..
When I asked her what a girl should do about it all, she answered…”Get in the middle and stay objective”
I rather liked that advice. We don’t have to take an extreme “either/or” approach to our health.
Educate yourself and make the best informed decision possible for your health and well being. Then take complete personal responsibility for that choice.
Magnolia
I have thought this very same thing for years…but the bitch slap notion is the best thing I have read yet!
I underwent a hysterectomy in Nov of 2005. I begged my doctor to leave my ovaries. but ended up with only one. I went into surgical menopause within 6 months, and felt horrible! The only way I can explain that experience is that my body completely betrayed me, and I felt dried up and emotionally crushed. I went crying to my gyne’s office to get relief…explaining I’d probably end up in jail otherwise! I’m now on the lowest dose of the Vivelle Dot, which is a patch I apply 2 x’s a week. My doctor wants me completely done with this at the end of the year. I’m thinking otherwise. You have to do what works for you. In the meantime, I’m an estradiol fan and staying there…..
After a pituitary tumor, I’m left without ANY sex hormones. My partner is a good sport, but I suspect he, as certainly I, would like a little help in that department!
I have been told by my natural health care professional that a topical testosterone cream is my answer. I have not yet pulled the trigger–still researching.
I also don’t make TSH, so am on Synthroid and Cytemel (T3 and T4, I believe) and the boi-identical Prometrium for progesterone.
…sigh…it’s a lot to take in!
It’s not difficult to quickly see how complicated this becomes, each woman with her own health/family history, her own collection of symptoms, her own journey toward achieving and maintaining health (including sexual health). Then it should be no surprise that there is no single path to attaining those goals.
We don’t have a great deal of history and research to tell us what the consequences are to women who have (nearly complete) organ failure (ovaries at menopause), and will likely live another 30 or 40 yrs, and what it means to live without those hormones. When the thyroid, pancreas or kidneys fail, there is no question about treating those conditions. When the ovaries fail, it’s not fatal, so we have a choice. Are we making the right decision? Up to now we have pieces of the story, with hormone therapy providing many benefits for some, and maybe some risks. Like so many things, we need to make an informed decision for ourselves.
My position as a women’s health physician is to listen to the woman and her current symptoms, consider her history, review options and as best able, help her understand what risks/benefits those options may have and then monitor the results and adjust as needed. It is a journey…….
As one of my colleagues says so aptly, ‘be a splitter, not a lumper’; treat each individual individually.
Good for you, Dr. DePree! You sound like the kind of physician we would all like to have a relationship with. Thank you.
Unbeknownst to me I had a severe case of endometriosis. I had a complete hysterectomy in Oct 2004. So without a uterus, a cervix, or ovaries (they had to go because they were imbedded in my uterine wall) they wanted me to supplement hormones – so they gave me the patch. My doctor, having been harassed by the insurance companies did not measure my blood for over a year. When he did it became evident that the hormones were not getting into my bloodstream. Long story short – I was inadvertently hormone starved for a year. I felt like an old lady. I got on bioidentical hormones in the form of a troche (nothing else was getting into the blood stream) and I felt like my old self. My biggest problem – my hormone doctor left the market and I’ve had a hell of a time finding someone I trust. I think I’ve finally found her though – time for a minor adjustment in my dosage – I can’t wait. Doctors who don’t specialize in hormone replacement tend to take the “safe” route, i.e. we don’t have research that says do it – so don’t. Is that best for the patient? I can’t imagine how that could be best. I can take hormones and feel like myself, or I can forego hormones and feel like a little old lady – getting more stooped over as the years progress. I also believe that with the right amount of hormones – the same amount that was in your body when you were healthiest – all of your bodily organs and functions with work better and stay healthier. Yes, nature starts to break us down as we get older – do I want to be 21 forever – even if I did it would be impossible – I do want to live like “myself” for as long as humanly possible. And I will fight anyone – bitch slap works – who tries to tell me I can’t. I can show you the slap marks to prove it!
OH — I forgot to give the name of the gel! OESTROGEL.