Bio-Identical (Natural) Hormones.
The growth of interest in natural hormones has been huge, and this increased interest is in large part to media reports about health concerns with synthetic hormones.
Major Drug Manufacturer Pressures FDA to Issue Statement About Natural Hormones:
On April 8th, 2008, the FDA published a consumer health information bulletin that addressed the myths associated with bio-identical hormones. Examples of these myths are “bio-identicals can cure cancer", “prevents senility”, and pointing out that you can’t “slim down” with hormones.66 A cause for concern was a statement by a senior official at the FDA “No data have been submitted to the FDA that demonstrate that estriol is safe and effective”. 66 Keep in mind that estriol is an estrogen that every women makes from her ovaries and declines sharply with menopause. This is a main ingredient for most bio-identical hormones. Also, there have been no studies presented to the FDA because estriol is readily available through pharmacies, so no manufacturer would go to the expense of doing FDA studies to get a hormone approved that is already on the marketplace.
This was widely reported in the media, and led to questions from several patients. The major synthetic hormone manufacturer, Wyeth labs has taken a huge financial hit after the large government report of potential dangers of synthetic hormone drugs. 1, 10, 11 In October 2005, Wyeth labs filed a “citizen’s petition” to encourage the FDA to ban doctors and pharmacists from prescribing compounded (custom) bio-identical natural hormones for their patients. 67 The main target for Wyeth labs was estriol, as no manufacturer has a patent to produce it, and it has been used generically in compounded natural hormones for years. The FDA has admitted there are no safety concerns about estriol, but are making statements in response to pressure by Wyeth laboratories. 68
The FDA acknowledged that there have been no adverse events associated with bio-identical hormones, and a study of 15,000 women with the highest level of estriol (the main estrogen that the drug companies wanted to have banned from competing with them) during pregnancy had 58% less incidence of breast cancer during the next 40 years. 67
Estriol has been studied and shown to have scientific proof for what we already know. Even though their has not been an application for a new use for estriol to the FDA, there is definitely credible evidence that it is safe and effective. Again, the FDA did not say there was any harm from bio-identical or natural hormones, they said they have been given no data from a manufacturer. Clinical studies have shown safety and effect of estriol. Estriol has been shown to prevent menopausal bone loss, improve menopausal symptoms, while being safe for women. 43 It has also been studied and shown to reduce the conversion of normal breast cells into cancer. 47 Estriol has also been shown to have positive effects on cardiac risk, urinary problems, skin, bones, and quality of life. 43,44, 45, 46, 47, 69 70
Bio-Identical Hormones, a Review:
The case for Bio-Identical (Natural) Hormones vs. Synthetic Hormones has built up rapidly over the past few years.
First, let’s review the terminology.
Bio-identical is a more appropriate term than natural hormones, but the terms are used interchangeably. They both refer to hormones that are indistinguishable from human hormones. Generally they are engineered from plant sources, but look exactly like human hormones. Again, they are indistinguishable from human hormones.
Synthetic (drug) hormones are products made by drug companies that do a job similar to human hormones, but are not human hormones. Some estrogens, like Premarin, are derived from the urine of pregnant mares. Progesterone look a likes, for example Provera, are in a class called Progestins. This means they are similar to progesterone, but are totally artificial, and not like anything found in nature.
Why synthetics in the first place?
Why the synthetic hormones? Well, drug companies cannot patent human identical hormones. There was a huge need recognized years ago for women who wanted to restore their hormones to youthful levels. The drug companies cannot capitalize on natural hormones, they will always be “generic”. So they had to produce synthetic substitutes that would make women feel better. These drugs accomplish that. The market is huge.1
Initially, estrogens were used alone (1960’s). Women felt better, but there was a significant increased risk of uterine cancer. Progesterone is known to protect the uterus, and decrease the risk of uterine cancer. This led to the development of progestins (synthetic drugs to achieve some of the effects of progesterone). It became standard of care to use an estrogen alone only in women with prior hysterectomies, and to use estrogen plus natural progesterone, or a synthetic progestin in women who had their uterus intact.2
Evidence mounted that not only did women feel better, but it appeared that hormone replacement therapy probably, and in some cases, definitely reduced the risk of certain diseases such as breast and uterine cancer, heart disease, and osteoporosis.3,4,5
Physicians began prescribing these synthetic hormones for women to decrease menopausal symptoms, and women as well as their doctors wanted to stay on them indefinitely because of perceived health benefits, and known well being benefits.
Women and their doctors noted that with hormone replacement, they were less likely to gain weight 6,7,9, 34,35,36 especially in the mid section, which is related to development of diabetes and heart disease. There was no doubt that these hormones improved symptoms. They also reduce the risk of osteoporosis4,5 and improve blood pressure and heart lipid profiles. 4,38,39
More recent studies showed that women on long-term hormone replacement were less likely to get Alzheimer’s disease.8,40 They also noted their minds felt sharper, and were able to think more clearly.
Study after study revealed improvement in quality of life issues, and showed potential for long-term benefits. Most of the studies used synthetic estrogen, but either natural progesterone or synthetic progestins were used. 2
The Big Change:
The Women’s Health Initiative study was designed to determine if long-term use of hormone replacement therapy in women did, in fact, reduce disease. The study followed tens of thousands of women over 5-6 years. 10,11 There were two arms of the study. One followed women with their uterus intact and used the horse derived estrogen, as well as the synthetic progestin and was reported in 2002. The other arm of the study followed women with hysterectomies, they were on the horse-derived estrogen alone. This study was completed this year. These studies comprised the largest ever clinical trial of synthetic hormones when used for a long period of time.
The results of the study were summarized in various publications. The message women received from reading the newspaper was “hormones cause cancer” or “hormones cause heart attacks”. The message to women was that if they continued their hormones, they would die of cancer or a heart attack. Two thirds of women stopped their hormones because of the way this study was reported alone.12 These women who were benefiting in quality of life discontinued this medication because of perceived risk from this study.42
But, let’s look at the data from the study
The horse estrogen plus synthetic progestin group had an increase of breast cancer. An individual women’s annual increase risk of breast cancer, even on these non-human synthetic drugs was 8/10,000, which equals 8 one hundredths of one percent. Not one percent, or even one tenth of one percent.10,13,14 Additionally the women in this study being treated with hormones were more likely to have mammograms, which may account entirely for the reported tiny increase in reporting of breast cancer. The risk of heart disease followed the same pattern, eight one hundredths of one percent, and mainly in women who only began hormones 20 years after they entered menopause! 10,13,14 In this same trial, there was a decrease of colon cancer and hip fractures.10,13,14 Also, studies have shown a decrease in Alzheimer’s with hormone replacement.8,40
The other group in the study was in the horse estrogen only group. In these women they noted a decrease in hip fractures, a possible decrease in breast cancer, and no increase in heart disease.11,15 There was no evidence of harm in this study. Yet women had stopped taking their hormones in droves and returned to menopausal symptoms for fear of breast cancer, and breast cancer rates were probably reduced! 15,12,11,42
This study had a huge impact on the lives of American women. Women talked about the perceived dangers of hormone replacement and recognized the benefits, but they were told that they caused cancer. The dry skin, vaginal dryness, night sweats, lack of sleep, loss of libido, hot flashes, forgetfulness, loss of energy, weight gain, increase risk of Alzheimer’s, increased hip fractures, and increased colon cancer, would have to be endured because of a perceived increase in breast cancer (8/100’s of 1% if taking horse estrogen plus progestin, and a decreased incidence of breast cancer if taking the horse estrogen alone).
For women experiencing symptoms of estrogen and/or progesterone deficiency, the potential marginal increased risk is likely outweighed by improved quality of life.
But why is there any potential increased risk of anything? Aren’t your hormones supposed to make you young? Shouldn’t there be a decrease in virtually all chronic diseases?
Enter Bio-Identical Hormones.
Estrogen:
Getting back to the basics. The estrogen used most commonly and in these studies was horse based. A woman has three basic estrogens, estriol, estradiol, and estrone. Estriol is the basic protective estrogen, and makes up about 80% of a woman’s circulating estrogens. Estradiol as well as estrone are the aggressive hormones, and are in lower concentrations. The common synthetic preparations use estradiol or estrone as the main ingredient, because these levels are commonly measured, and these estrogens have the most osteoporosis protection (which can also be easily measured). But they don’t necessarily convey the health protection of estriol. The combination of all three human estrogens is commonly referred to as Tri-est, and some doctors drop the estrone-and use bi-est. The concern is that estrone may be the cancer causing element in the large studies, but there is little proof to support this. A key element here is that estriol, the protective estrogen which is missing in virtually all synthetic drug hormones is protective against cancer.11,15,14,10,16,17,18,43,47
Estrogen Pills vs Cream?
The other key element is the way the estrogen is taken. For years, the most common way for a doctor to prescribe a medication is in the form of a pill. Estrogens can also be given as a transdermal, which means a skin cream. When an estrogen is given as a pill it is recognized as being foreign substance by the liver, and body has a response to it. This response may be negative, can be measured, and appears to be a major contributing factor to the negative effects of oral hormone replacement.50,55 When taken as a cream, particularly a bio-identical form, it is unrecognized as coming from some other source than the ovaries. This makes it indistinguishable from the estrogen that a woman naturally produces. Amazingly, just changing estrogen delivery from a pill to a cream has been shown to convey multiple benefits. These include significant weight loss, 35,36,51 improved circulation and blood pressure, better cardiac lipids (cholesterol, triglycerides) and heart function,39,51,52,53,54 less wrinkling and healthier skin.44,45,46 It also appears that the estrogen given as a cream rather than pills may be protective against breast cancer.47,48,49 Bio-Identical estrogen given as a cream is highly effective in reducing virtually all symptoms of menopause, and the dose can be customized.56,57
Progesterone.
Progesterone is natural and is a human hormone. Progestins are synthetic drugs that resemble nothing found in nature, yet they are the most commonly prescribed when progesterone levels are low. Remember, progesterone and progestins are not the same thing. The synthetic progestins have been shown to disrupt blood vessel walls (this leads to inflammation which leads to athersclerosis) and negative effects on the heart and circulation system.19,59,60,61 This is likely the reason that the Women’s Health Initiative Study found a tiny increase of heart attacks in women on synthetic progestins (again, only 8/100ths of 1 % in women who took them starting after 20 years of menopause, but still an increase).14 Synthetic progestin drugs also decrease bone density, which is a cause of osteoporosis. 28,24 Synthetic progestins have been shown to slightly increase the risk of dementia.26
Progesterone, on the other hand, is totally natural. The reason commonly cited for using progesterone in hormone replacement therapy is that it prevents uterine cancer. However, all hormones have more than one target organ. There are other benefits for using natural progesterone besides preventing uterine cancer. Natural progesterone does not cause irritation to the circulatory system, and is protective to the heart.23,19,59,61,62 Natural progesterone is not only protective of the heart and circulation system, it also protects the brain and mood.25 Natural progesterone protects against bone loss, either alone, or in combination with estrogen.3,4,5,27 Natural progesterone also has protective effects against breast cancer. 58,59
Estrogen and progesterone act together when the hormones are on cruise control. When your periods are regular, you lack PMS, bleeding is even, your mood is level, this signifies your hormones are balanced.
During pre-menopause, which may occur several years before menopause, the progesterone declines, and estrogen becomes relatively dominant. This frequently leads to changes in the monthly cycle, abnormal bleeding, fibroids and increased PMS. Closer to menopause, the time commonly called peri-menopause, estrogen begins to wax and wane. This leads to the mood swings, loss of libido, forgetfulness, hot flashes, sleep disruption, dry skin, weight gain, and wrinkling. Menopause is defined as no menses for a year. The ovaries no longer produce estrogen or progesterone. Secondary hormones like testosterone, DHEA, and pregnenolone all decline as well. This sets the stage for faster aging, and increased symptoms described earlier. Eventually, years later, the body’s thirst for estrogen dries up, and the hot flashes and night sweats go away. The weight gain, wrinkling, degeneration of muscle and bone, and development of athersclerosis continues.
Restoring these hormones to youthful levels (not just one of the three estrogens, or a fake progesterone) improves well being, restores bone and muscle, improves circulation, reduces heart disease, restores the skin, protects against cancer, improves libido, elevates the mood, restores vigor, improves sleep, reduces hot flashes and night sweats, reduces Alzheimer’s disease, reduces incontinence, maintains weight and improves quality of life.18, 20, 21,17,22, 21,3,29,44,45,46,47,56,57,58,59,61,62,63,65
Estrogen has a crucial role in fat distribution. Estrogen deficiency leads to the mid section obesity, which is observed as women age. Estrogen replacement slows this down significantly or stops this process, and helps maintain a youthful figure.6,7,9,30,31,32,33,35,36,51
Why hasn’t anyone told me about this earlier?
There are a handful of reasons. First, we knew for a long time that declining or imbalanced hormones were to blame for menopausal symptoms (as well as PMS, endometriosis, infertility, weight gain, acne, facial hair). We also knew that hormone replacement eased many of those symptoms, and we assumed they would reduce chronic disease. And they do. However drug companies cannot patent human identical hormones. They had to come up with something that might mimic the benefits of bio-identical hormones, and protect their investment. This led to the use of horse hormone derivatives. Currently drug companies are using natural products (soy beans) to create drugs that are plant based, but still look exactly like a horse’s estrogen makeup (you can’t really call these “natural”). This was also the reason synthetic progestins were invented.
For years doctors assumed they were just as safe as the real hormones. And keep in mind doctors frequently learn about medications through the drug company’s sales force. This is why there is legislation to limit drug company’s influence on doctors (how much they can wine and dine them).
The bio-identical hormones are generic, and available through compounding pharmacies. There are no big drug companies sending their sales forces out to doctors offices to explain why they work so well, leaving samples, and buying the staff lunch. Also, the bio-identical hormone prescription has to be custom written by a provider with significant expertise with hormones. The blood levels are monitored, the patient is given detailed instructions on how to apply or take them. They are highly customized. Gone are the days of the “one size fits all” pill. All women are different, and they clearly have different hormone requirements.
Generally, the natural bio-identical hormones are taken as combinations of capsules, drops under the tongue, or creams applied to the skin.
When making a decision about restoring your body’s hormone balance, read everything you can, talk to as many people as you are able to, give it serious consideration. If you opened up your newspaper and saw a headline “Hormones Cause Cancer” you should be skeptical.
We age faster as soon as our hormones decline. Many women want the second half of their life to be as productive and fulfilling as the first half.
Dr. Charles Mok, D.O. American Board of Anti-Aging Medicine
Allure Medical Spa 586-992-8300
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Dr. Charles Mok, D.O. American Board of Anti-Aging Medicine
Allure Medical Spa 586-992-8300