What Are Hormones?

Hormones are molecules that are synthesized and secreted by specialized cells often localized in endocrine glands in the body. Hormones are released into the blood stream and exert biochemical effects on target cells. Hormone action is determined by the presence of specific hormone receptors located either on the cell surface or intracellularly in the target cells. Hormones turn on the cellular machinery and therefore cause increased metabolism, increase in protein synthesis, increase in cellular repair, and increase in cell replication. Some of the hormones such as insulin, thyroid, testosterone, estrogen, and progesterone are well known to most people.  But how well do people understand what they do?

All aspects of aging are influenced by hormones. As we age cellular receptor sites become less sensitive to stimulation by hormones, thus requiring an increased amount of hormone to affect a cellular change. This is precisely why people need optimal levels of hormones. And even though their levels might be normal, they still need more hormones in the body to improve and feel better. (This is particularly true with thyroid.) These changes in hormones result in decreased healing and repair of tissues. Research has now proven that hormone therapies are valid means to improve and prolong quality of life, thus showing that deficiencies in hormones and endocrine dysfunction can contribute to the signs and symptoms of getting old.  Nothing reverses aging. However, hormones can slow down the process and help us maintain our good health.

Unfortunately, the technology to accomplish this age reversal by genetic engineering is not currently available. In the meantime, we must take advantage of the current state of the art, preventive medicine techniques which include avoidance of risk factors of disease, optimum nutrition, adequate exercise, caloric restriction, antioxidant therapy, and optimal hormone replacement. We can certainly slowdown that aging process to achieve less deterioration, less illness, a better quality of life and to feel and function better. This is true Preventive Medicine.

​

Benefits of Hormone Replacement Therapy (HRT):

​

In 1990, there was a landmark article published by Dr. Daniel Rudman in the New England Journal of Medicine. He and others showed that hormone deficiency was in part responsible for increased body fat, decreased muscle, decreased strength, decreased bone and skin thickness. Replacement of hormones resulted in overwhelming improvement in signs and symptoms of getting old. The findings of this famous study were consistent with the hypothesis that it was the deficiency of a hormone that contributed to the age-related changes. Many studies have since shown the same clinical utility of hormone replacement to effect clinical improvement in many of the signs and symptoms we encounter with aging.

​

Investigators are now combining various hormones and are seeing even more improvement. Dr. Mark Blackman, an endocrinologist from John Hopkins, recently published his findings in the Journal of Clinical Endocrinology and Metabolism. In this five-year study, he combines testosterone, estrogen and progesterone. Although there were different arms within the study, all men and women benefited from hormones, while those not on hormones did not. This investigator discovered again that the deficiency of hormones leads to symptoms and illness that were improved and prevented by hormones. Improvements seen were:

​

• Increased breakdown of fat, weight loss and reduced body fat.

• Decreased incidence of heart disease and atherosclerotic plaque.

• Increased energy and exercise capacity.

• Improved vitality and quality of life.

• Increased strength, endurance and muscle tone.

• Improvement in hair, skin and nails.

• Improved sleep and well-being.

• Reduced levels of cholesterol and triglycerides.

• Less incidence of heart disease and diabetes.

• No increase in cancer was seen with any hormone.

• Progesterone decreases the incidence of breast cancer.

​

All hormones showed beneficial health effects, improvement in body composition, lipid profiles, cardiovascular risk factors, and increase in muscle strength and fitness. What is difficult to understand is why this article did not make national headlines? It can be concluded from this and other studies that hormone supplementation can reduce the incidence of major illness and thereby prolong life. It is not only the longevity that is important, but more so the quality of life, free of illness and disability. It should be every physician’s goal to extend the health and vigor of our middle-aged years into the latter years. The research and science is there. Physicians just need to learn to apply it. HRT is the ultimate of preventive medicine.

​

Hormone deficiency is responsible for many of the symptoms that occur as we get older. Hormone deficiency is a relatively simple malady to treat. Severe deficiency over prolonged periods might result in illness, physical impairment, disability and increased morbidity and mortality. Despite this evidence, patients are being seriously undertreated or ignored. Barriers to treatment can be addressed by educational programs aimed at increasing awareness and knowledge about natural hormone replacement therapy and its effectiveness.  In spite of effective treatments being available, most individuals go without treatment. It is disturbing that the medical research papers and advances in diagnosing and treating hormone deficiencies has not revolutionized treatment practice. I frequently lecture to medical specialty academies to introduce the concept and the medical basis for such therapy. Optimal hormone therapy can help improve the outcome of treatments for many medical specialties. It might take years for medical school curriculum to teach this information and even longer for it to become the standard of care.

​

The benefits of HRT are dramatically enhanced with exercise. Hormone replacement along with a strength training program greatly enhances exercise tolerance, muscle strength, endurance and prevents fatigue. Exercise enhances our sense of well-being, decreases weight and helps lower cholesterol. Many people complain that they see no weight loss, strength improvement, fat reduction or better endurance in spite of consistent exercise. This is frustrating for them. However, when hormones are added to the formula improvements are seen. Hormone replacement also assists one in gaining the energy and desire to exercise.

​

The basics for optimal health and longevity are proper diet, exercise, nutritional supplementation and natural hormone replacement. HRT slows cellular degeneration and allows improved function and healing. This results in less disease and illness, a slowing of the aging process and a better quality of life. The scientific research has been impressive, the results dramatic, the public demand incredible. Don’t be without it!

​

Why is Hormone Replacement Therapy (HRT) Important As We Age?

​

Hormones decline in all people as they age. Many physicians assume this is the natural way it should be. If a younger person were to be diagnosed as having a hormonal deficiency, it would be quickly corrected. However, the same low level in an older individual is considered normal for their age and not something we treat. Normal is a relative term. No one wants the hormone levels of an 80-year-old, but labs report this low level as “normal” even though it might be only 20% of the level of a 30 year old. Researchers from around the world have now shown that the hormonal deficiency associated with age should be corrected to that of a younger person. When patients see and feel the improvement, they embrace it whole heartedly. It is not until one tries this new therapy and experiences the tremendous increased vigor that one realizes the harm that is being caused to the body by the lack of these hormones. The added benefit is that it is healthy too.

​

Thyroid, estrogen and progesterone have been prescribed for many years, but optimal hormone replacement is new. It has become logical therapy to replace and balance all of the hormones at the same time to a more optimal physiologic level instead of maintaining lower or mid normal levels. This is the difference between optimal hormone replacement in comparison with the standard medical therapy. Don’t wait for levels to be technically below a normal range. Accept a low normal level as not optimal and replace the hormone to high normal or optimal levels. Fortunately, many physicians as well as patients are able to key into the concept of optimal hormone replacement.

​

It has been shown that many changes seen in normal aging, including osteoporosis, muscle atrophy, sleep disorders and decreased sociability are in part caused by a decrease in hormones. Aging in man is associated with reduced protein synthesis, decreased lean body mass, decreased bone mass and increased body fat. The body composition changes are consistent with the progressive decline in the secretion of hormones. Much of what goes wrong in old age is the effect of our hormones no longer maintaining the balance that they once did. In fact, the diseases that have become associated with normal aging, such as diabetes, heart disease, and hypertension are largely a result of what happens when the correct balance of hormone levels is upset. By restoring the proper hormone balance, immunity is restored, and this can prevent many of the diseases associated with the aging process.

​

Many patients are typical, middle-aged, healthy people who experienced gradual increased symptoms such as decreased energy levels, decreased sense of well-being, laziness and lack of desire for common daily activities. Patients tend to lose muscle tone, gain fat around the midsection, and experience thin hair and thin skin. In addition to the symptomatic, degenerative problems, they will also experience increased cholesterol as well as signs of heart disease and arthritic change. Within six to twelve months of hormone replacement therapy, patients have noticed reshaped bodies, fat disappearing, increased muscle tone, and the energy of a younger person. Patients report an improved sense of well-being and an improved outlook on life. There are tremendous health benefits; there are great feel good benefits.

​

Unfortunately, nearly 90% of the patients we see who are taking “natural hormones” from other doctors are on an inadequate regimen. How do we know? When we measure the blood levels, they are near zero. In order for the hormones to be beneficial, the serum hormone levels must be kept within the optimal, upper limit of normal levels for a younger person. Most physicians are not trained to target optimal levels.

​

Many physicians do not understand how to prescribe the correct doses. They are not aware of the target optimal levels based on blood tests (not saliva tests). They might not be aware of the many options in the compounding of a natural hormone in order to provide a type that is absorbed and metabolized by the individual patient.

​

First and foremost, the patient must insist that the physician explain, monitor and optimize the hormone levels in order to guarantee that the therapy provides the maximum benefit.

​

Women who go through menopause will notice dramatic changes in skin thickness, texture, hydration and tightness. Women who stop hormone therapy notice the same disturbing changes. Literature in dermatology journals demonstrate that loss of thyroid, estrogen and testosterone hormones are responsible for this detrimental effect on skin. The only way to treat and prevent the changes in skin collagen, elastin, and prevent wrinkles is through hormone replacement. More importantly, however, are the changes within. The outside skin clearly displays signs of aging, but the inside also incurs significant deterioration that is not visible. This might be the reason that so many mid-life women and men say they just don’t feel as well as they would like. So much of this can be helped if treated early. When you go to that high school reunion, you’d rather hear, “Wow, you look great!” instead offering how much you’ve aged.

​

The Importance of Replacing Deficient Hormones:

​

Thyroid, testosterone, estrogen, progesterone, DHEA and growth hormone — to levels we had in our youth is beneficial to both our health and quality of life. This booklet is an overview of biologically identical hormone replacement for men and women. This specialty of medicine is growing at an impressive rate due to the increasing awareness of the health benefits of natural hormones and the detrimental effects of synthetic hormones. The first printing of this booklet was in 1998. A lot of media attention and medical studies have focused on hormone replacement in the last few years. This is our 4th revision and is reflective and explanatory of the recent mystery and misinformation about hormones. An additional excellent reference source on natural hormones for patients and physicians is a book I authored in 2002 entitled Natural Hormone Replacement for Men and Women: How to Achieve Healthy Aging.

​

Conventional medicine has always held the belief that aging is inevitable and that the progressive deterioration that occurs in our adult years cannot be altered. This is simply not true. We have also been lead to believe that the diseases of aging, such as heart disease, stroke, cancer, and senility, are all a part of the normal aging process. Fortunately, there is an exciting revolution in science and medicine that identifies hormone replacement as preventive medicine. The downward spiral of physical and mental decline that we have come to accept as a natural part of growing older is becoming recognized as somewhat controllable and preventable. The most effective solution to any disease process is the prevention of that disease. We are entering an era where mainstream medicine will focus on slowing down the aging process and thereby achieve prevention of both the illnesses of aging as well as the aging. One of the most important and successful treatments is optimal hormone supplementation. The amazing health-protective benefits of hormones are growing in understanding, acceptance, and application. Research has shown that maintaining our hormone levels in a youthful state can prevent the debility and illness that accompany the aging process. Obviously this will lead to increased longevity by preventing the illnesses that usually lead to our demise. However, most importantly is the fact that our quality of life in our later years will be significantly enhanced.

​

Over the last 50 years of research in the fields of endocrinology and immunology have improved our knowledge as to how and why we age. The rate and incidence of disease formation, as well as the rate of aging, are partially controlled by our endocrine and immune systems. These two systems are responsible for the adaptation and change of our bodies in relation to the aging process. The endocrine system regulates our body’s temperature, reproduction, growth, aging and immune system. Communication between the nervous system, the endocrine system, and the immune system makes it possible for us to adapt and survive in our environment. It is through hormones that these systems interact to accomplish this mission. Hormones are molecules that are released into the bloodstream and exert biochemical effects on distant organs and cells. Hormones can affect every cell in the body by activating a receptor site on the cell and thereby causing an internal activation of protein synthesis and activity. The hormones affect is determined by a specific receptor site on the target cell. Hormones might have different actions on different cell types in different tissues. Hormones serve as messengers from the central nervous system telling our internal organs how to function. A decrease in the production of hormones begins in middle age and continues to diminish in a linear fashion until old age.

​

Hormones are either proteins or derivatives of cholesterol. These molecules are manufactured in endocrine glands, which include the adrenal glands, the testes, ovaries, pancreas, thyroid, pituitary gland, and pineal gland. When there are degeneration and aging of the organs, the levels of hormones diminish. In addition, as we age, the specific receptor sites in the cells tend to change and become not as receptive to the hormones as they once were in our younger years. Whether the problem is low hormone levels or hormone resistance, the solution is optimal hormone replacement.

​

Whatever the cause may be, any decrease in the stimulation of the receptor site will result in a decrease in the stimulation of the cell, decrease in cellular repair, decrease in protein synthesis, the inability of the cell to regenerate and the gradual destruction of the cell. This is what occurs with age. A deficiency of hormones will, therefore, result in an imbalance in this very precise, self-regulating system. For many years, medicine has recognized the health benefits of replacing these waning hormones. For most physicians, synthetic hormones were the only option. Now it is possible to produce natural hormones that in every way match those produced by the body. Most hormones can be derived from plants, such as soy and yams. We have come to understand that synthetic hormones, which are chemically different than those naturally found in the body, can cause a whole host of side effects and even cancer. It does not make sense whatsoever to replenish with chemically different hormones when bio-identical hormones, to which our bodies are accustomed, are available.

​

There is a growing change in how we practice medicine. People are beginning to realize that they no longer have to accept the fact that their health, appearance, and function must deteriorate. They no longer want to accept growing frail and feeble. This new evolution is a culmination of research efforts over the years from some of the most distinguished medical and scientific research centers in the country. Physicians have finally realized that science has now given them the tools to enhance the quality of life by preventing deterioration through hormone replacement. Science is creating a new paradigm of preventive medicine by allowing our bodies to remain strong, healthy and vigorous. For centuries man has been searching for the Fountain of Youth, that potion that would stop the aging process. Research has now shown that part of the answer exists within our endocrine system. Medical journals have well-documented studies on the health benefits and feel-good benefits of HRT. Several medical references are listed in the book by Neal Rouzier, M.D., Natural Hormone Replacement for Men and Women: How to Achieve Healthy Aging.

​

Hormones control virtually all of the functions of the body including our reproductive, immune and metabolic systems. Hormones can actually control our overall physical and mental health. As the levels of hormones decline so do we decline both physically and mentally. We lose our energy, vitality, and health, as well as our longevity. By restoring these hormones to their youthful levels it is now possible to restore our youthful zeal and energy and to strengthen and bolster our bodies as well as our minds. We can improve many of the symptoms that we have come to associate with old age. We can also regain the youthful resilience that enables us to cope gracefully with the stressors that challenge us every day.

​

Hormone replacement therapy, however, is not a panacea. It will not reverse aging. It will not keep us permanently at one age. We will still continue to age and lose cells secondary to a process that is regulated genetically. With hormones, we can slow the precipitous decline that occurs after midlife. There will be no sudden falling off in our physical and mental health. We will stay resilient. There will only be a gradual transition that will be much less noticeable than it would be without the hormone replenishment. The purpose is to simply replenish the hormones that already occur naturally in our body and boost them back up to the appropriate medically sound levels necessary to maintain youthful health and vigor. Again, the key is to replenish all of the deficient hormones back to a more youthful balance, thereby producing a synergistic effect between the hormones. Which hormones to replenish, how much to replenish and how to adjust the hormones so that they have a synergistic effect is the art and science of the new specialty of natural hormone replacement medicine. I prefer the term preventive medicine. Vitamins, diet, and exercise are important, but hormone replacement is the only therapy that I have seen that can restore energy, make patients feel and function better and provide long term therapeutic protection. The next few chapters of the booklet will review each of the hormones, their health benefits as well as the detrimental effects of being without the hormone.

​

The Testosterone Quiz (For Men):

​

Men, are you currently experiencing the following symptoms?

• Declining sexual function, such as lower libido

• Lower energy level

• Loss of muscle mass

• Erectile dysfunction

• Weight gain, especially fat mass around the waist

• Depressed mood

• Declining strength and exercise endurance

• Poor self-esteem and worsening procrastination

• Generalized aches and pain

• Poor sleeping at night

• Increased irritability and decreased ability to deal with stress

​

Testosterone For Men:

​

Testosterone replacement in men has been shown to be effective in providing many health benefits. Testosterone replenishment results in increased muscle strength and lean body mass, improved sexual response, reversal of impotence, and improved body composition. Testosterone has also been shown to prevent osteoporosis, arthritis and degenerative joint change. It improves the sense of well-being and depressed mood that are frequently seen in andropause (male menopause). It has also been shown to improve memory, as does estrogen in women. Most of all it has been shown to protect against cardiovascular disease in both men and women.

​

Men who receive testosterone replacement consequently report that they feel sexier, stronger and healthier. They state that it makes them feel as they did when they were in their prime. After all, this is what replenishment of hormones is all about. It is about restoring hormones to youthful levels so you can feel as you did when you were at the peak of your physical and mental ability. Testosterone can slow down the physical decline that robs men of their energy, strength and libido. Testosterone can restore muscle tone and improve stamina. Testosterone can restore healthy sexual excitement and desire, which in turn results in an improvement in mood and overall well-being.

​

Testosterone is responsible for the sex drive of both men and women. As testosterone diminishes with age, so does the sexual functioning in both men and women. Restoring testosterone to youthful levels can reverse this situation. All too often, men and women automatically assume that as they age, their sexual capacity will diminish. There is no need to accept this loss of sexuality. Testosterone can play a critical role in helping to preserve and even restore sexual desire and function so that we can live our extended life span with the same excitement and enthusiasm we enjoyed in our youth.

​

Physicians are witnessing an explosion of interest in testosterone as a result of our growing realization that testosterone levels decline with age and that many men suffer serious consequences to their physical and mental health as a result. In women, it is expressed as menopause, whereas in men, it is expressed as andropause. Many of these symptoms and disease processes that we have come to accept as the result of normal aging are processes that are actually secondary to low testosterone levels and are easily correctable. Testosterone supplementation results in increased muscle strength, muscle size, increased energy level, decreased fat, and increased desire and endurance for exercise. As a result of this, the FDA recently approved the testosterone patch and topical gel. Now both men and women may be treated for their sex hormone deficiencies.

​

How many of the supplements that we take are not only beneficial to our health but also result in increased energy, increased stamina, and an elevated mood? What other supplement can build a strong body, strong muscles, strong bones, strong ligaments, and trim fat at the same time? An added benefit is an improved desire to exercise due to less exhaustion and lethargy. Clearly, testosterone is shown to have a positive impact on men’s health and well-being, our mood and our ability to learn and retain information.

​

There is good evidence that testosterone deficiency plays a role in heart disease. Despite many well-designed clinical research studies documenting a broad range of cardiovascular benefits from testosterone, it is virtually ignored by U.S. cardiologists. Patients with the greatest arterial blockage have the lowest testosterone levels from one recent study of 2500 men. This study from UC San Diego not only showed that men with higher baseline levels of testosterone had less cardiovascular disease, but supplementing to youthful levels prevented worsening of cardiovascular disease. In spite of this data available in the medical literature, physicians remain somewhat oblivious or resistant to the benefits of testosterone.

​

Testosterone supplementation helps reduce obesity, raise lean body mass, normalize blood clotting and raise the good HDL cholesterol, all of which decrease the incidence of diabetes and cardiovascular disease. It also prevents cognitive decline and Alzheimer’s Disease even better than estrogen in women. A recent medical study showed testosterone reduced C-Reactive Protein levels (CRP) a measurement of inflammation in blood vessels. Testosterone protected against heart attacks and progression of heart disease. Yes, testosterone has been demonstrated to increase lifespan. A recent study from the Annals of Internal Medicine demonstrated that men with the higher levels of testosterone lived the longest. Men with lower levels of testosterone did not live as long. This makes one wonder why most physicians fail to recommend testosterone for all men.

​

Testosterone should not be used if one has active prostate cancer. Multiple medical studies have proven that testosterone has not been shown to cause prostate cancer. In fact, low levels of testosterone are associated with more aggressive tumors. However, if one does develop prostate cancer, testosterone supplementation might accelerate the growth levels of the tumor. Therefore, there is a need to monitor the PSA on a regular basis to assure that one does not develop prostate cancer. Prostate cancer is the most common cancer in men. It can often be detected by an annual PSA test.

​

A recent summary article appeared in the New England Journal of Medicine, January 2004. The authors concluded, “We reviewed decades of research and found no evidence that testosterone therapy causes prostate cancer.”  In fact, prostate cancer became more prevalent later in life when testosterone levels decline. The authors found no connection between higher testosterone levels and prostate cancer or any evidence that testosterone treatment provokes cancers. Researchers found no evidence that testosterone therapy causes prostate enlargement (BPH). More importantly, testosterone was found to significantly protect against heart disease. Testosterone was found to be a beneficial and safe hormone.

​

The Testosterone Quiz (For Women):

​

Women, are you currently experiencing the following symptoms?

• Feeling tired and fatigue easily

• Feeling "cold all the time” or your hands and/or feet are cold

• Severe PMS symptoms and/or heavy menstrual flow

• Hot flashes or night sweats

• Sexual dysfunctions such as lower libido, dry vaginal wall and/or poor lubrication

• Weight gain

• Depressed mood

• Poor skin, nail and hair quality

• Looking and feeling “old”

• Poor sleeping at night

• Declining physical endurance and exercise capacity

• Poor self-esteem

​

Testosterone For Women:

​

Even though testosterone is widely known as a male hormone, it is also a critically important hormone for women in that it plays a crucial role in the physical and emotional health of women. Too many women mistakenly think testosterone is only for men and resists the benefit of taking testosterone.  Even many of the doctors who may prescribe estrogen and progesterone but failed to prescribe testosterone for women. The pharmaceutical industry was the first to realize the importance of this, and they have begun to market a combination estrogen and testosterone tablet which is, unfortunately, synthetic. The synthetic hormones can adversely affect the liver and should not be used. The safe, natural testosterone only should be used and is available from specialty compounding pharmacies.

​

Testosterone is produced both in the ovaries and adrenal glands of women and is an important hormone for normal female sexual development. Women also lose their libido as they age which is secondary to loss of serum testosterone. Lack of testosterone also contributes to symptoms of menopause and lack of libido and sexual responsiveness. Replenishment of testosterone in women contributes to the enhancement of sexual drive, relief of menopausal symptoms, restoration of energy, strengthening of bone, prevention of osteoporosis and improvement of an overall sense of well-being and zest for life. Many women do not realize that testosterone improves their skin, muscles, bones, tendons, and joints. Older patients commonly complain about their skin becoming so thin, primarily on their arms and hands. Most women are unaware that the best hormone for the skin to prevent thinning and wrinkles and increase collagen and elastin is testosterone.

​

Many physicians and women remain unaware that testosterone is much better for protecting against bone loss than estrogen, yet it is seldom mentioned as a treatment. A small amount of replacement with testosterone gel can make an incredible difference that many women have not been able to enjoy up until now. The correct dose of testosterone replacement will be determined by body weight, age and blood levels.  Testosterone supplementation helps reduce obesity, raise lean body mass, normalize blood clotting and raise the good HDL cholesterol, all of which decrease the incidence of diabetes and cardiovascular disease. It also prevents cognitive decline and Alzheimer’s Disease even better than estrogen in women. A recent medical study showed testosterone reduced C-Reactive Protein levels (CRP) a measurement of inflammation in blood vessels. Testosterone protected against heart attacks and progression of heart disease. Yes, testosterone has been demonstrated to increase lifespan. A recent study from the Annals of Internal Medicine demonstrated that men with the higher levels of testosterone lived the longevity.

​

In summary, testosterone is a hormone secreted by the ovaries, adrenal glands and testes. It is both a male and female hormone. It contributes to increased muscle mass, strength, endurance, decreased fat, increased exercise tolerance, enhancement of well- being and mood. There is an increase in bone density and prevention of osteoporosis, improvement in skin tone and healing capacity, and increased libido and sexual performance. It prolongs the quality of life by slowing the diseases of aging such as cardiovascular disease by decreasing cholesterol and increasing HDL. Testosterone is a memory enhancer and protects against the formation of Alzheimer’s disease. It is equally as important and beneficial in females as well as in males. A recent study in JAMA explored all the benefits of testosterone and called it cutting edge medicine. The NEJM reviewed testosterone replacement for women and found it the best therapy for improving energy, along with estrogen and progesterone. Don’t confuse natural testosterone with the synthetic testosterone analogs. Use only the natural testosterone and not the synthetic. It’s healthy for you and you’ll feel good too.

​

Menopause: To Bleed or Not to Bleed:

​

Menopausal women taking hormones do not necessitate menstrual cycling. The hot topic for celebrity talk shows and celebrity books is bioidentical hormones. The media has highlighted the term “bioidentical hormones” thereby making it a familiar subject for both women and men, especially those coming to grips with the aging process. Now we can further define the term “natural” and specify & “bioidentical” which gives everyone a new understanding and appreciation for hormone replacement.

​

Out of this media frenzy have emerged new “experts” with “expert” opinions on the right way to take hormones. One of these “expert” methodologies of hormone replacement unfortunately has made many women apprehensive. Some are so displeased that they avoid taking hormones altogether. Some experts theorize that cycling (creating a period every month) is recommended and natural. The implication is that women menstruate while they are “young” and healthy. In order to maintain that same healthy status all menopausal women should continue to menstruate. This “cycling” is done by stopping progesterone for one week of each month and thereby creating a menstrual cycle. Most women find this recommendation unsatisfactory. If women believe that taking hormones requires that they have a period, most women choose to pass on hormone replacement.

​

What is cycling? It is the fall of women’s hormones that results in menstruation. If a woman stops the progesterone for a few days every month she will cycle and bleed. This is possible even if you have been years without a period, unless, of course, you have had a hysterectomy. Just because it is “natural” in younger women does not mean it is necessary or beneficial for menopausal women.

​

First of all, hormone replacement therapy does not put one in a state of pregnancy. During pregnancy the levels of estrogen might be in the hundreds. On estrogen replacement, ideal estradiol levels are typically 60-100 pg/dl, far from that seen in pregnancy.

​

Secondly, the reason a woman menstruates is to clean the uterus in preparation for the eventual implantation of a fertilized egg. If one is not interested in becoming pregnant, there is no physiologic reason or benefit to menstruate.

​

A recent article in the Obstetric/Gynecological literature claimed that unexpected vaginal bleeding was the most common reason women stopped taking HRT. The cessation of periods was one thing that women welcomed with menopause. The medical literature often addresses how to stop and prevent postmenopausal vaginal bleeding so that women will be comfortable in continuing HRT.  We advocate increasing progesterone to prevent post-menopausal bleeding. With the appropriate balancing of estrogen and progesterone, women should not bleed and will be more satisfied with continuous use of HRT. Also, since estrogen and progesterone are so important, why take them for only three weeks per month and stop them to bleed in the fourth week? A woman would lose the protection and benefit of estrogen and progesterone for 25% of the time.

​

For years, women have been treated with birth control pills taken continuously and not cycled to control PMS. It is the fall of women’s hormones that takes place right before their periods that causes the symptoms of PMS. By taking birth control pills continuously, a woman can avoid this drop of hormones and the symptoms of PMS. The pharmaceutical industry has now caught onto this and promotes a new birth control pill that is cycled for bleeding only every four months instead of monthly. The researchers claim that while no menstruation is necessary, the cycling allows women to menstruate every four months to make them feel more “normal.” We now realize that even pre-menopausal women do not need to menstruate, let alone post-menopausal women.

​

Remember, cycling involves stopping the hormones for a week each month. Another reason not to cycle is the loss of protection that takes place when the progesterone is not present. Bioidentical progesterone protects the breasts and uterus against cancer. The bleeding that takes place with menstruation is not what protects the uterus against cancer. It is the direct effect of progesterone on the uterus that protects it. Stopping progesterone for a week means that the body is without the protective benefits of progesterone for those days. It makes no sense to lose the important protective benefits for seven days every month.

​

Recent studies have shown that Provera (medroxy-progesterone) increases the risk of breast cancer and increases the thickening of the breast tissue. It does this by direct stimulation (up regulation) of estrogen receptor sites in the breast. One study showed that Provera increased breast stimulation by 400% over baseline. The same study showed that bioidentical progesterone (different from Provera), does not stimulate breast tissue as it down regulates receptor sites in the breast. Therefore, why lose this protective effect of progesterone by stopping it for 25% of the month which means you lose 25% of the protection? There is a condition known as “endometrial hyperplasia.” This condition causes increased thickening of the endometrial stripe (uterine lining) which is a precursor to cancer. This condition must be treated to avoid the development of cancer. The treatment is high dose progesterone (or Provera by conventional physicians) to shrink this tissue. If repeat ultrasound does not show a decrease in endometrial lining, then the dose of progesterone is doubled. The shrinkage of the endometrial tissue is a result of the direct stimulation by progesterone. The protection does not occur because of the shedding of the lining. A constant sufficient dose of progesterone is the better protection against cancer. Progesterone should never be stopped for any reason!

​

In summary, women on hormone replacement therapy do not need to cycle (stop the progesterone) and bleed on a periodic basis. There is no substantiated benefit to the body to regularly bleed. And it certainly makes hormone replacement therapy and its many protective benefits a more attractive and convenient regimen for women.

​

Bioidentical Hormones:

​

You might ask, “If there are hormones available that are natural to my body, why do doctors prescribe synthetic hormones?” The explanation involves the powerful pharmaceutical industry in the United States, politics and economics. The molecule of the natural hormone is identical in structure to the hormone naturally found in the body, Pharmaceutical companies cannot patent natural or bioidentical compounds that already exist in nature.

​

However, they can patent chemically different molecules that are highly profitable. A patent will guarantee that a pharmaceutical company will have an exclusive right to manufacture and profit from their product. After the tremendous monetary investment that goes into developing and studying a pharmaceutical product, it is logical that the pharmaceutical companies would want their investment protected with an exclusive, patented product. Therefore, there is little research and minimal marketing of natural hormones.  Where do these natural hormones come from? The pure biologically identical (human identical) hormone is either extracted from plants or synthetically manufactured. What is most important is that the end product is a molecule identical to the hormone molecule found naturally in the body. This applies to all hormones — thyroid, estrogen, progesterone, testosterone and DHEA.  One can get bioidentical hormones from compound pharmacies.

​

Aren’t health food store products natural? Products in health food stores provide people with a variety of natural options, usually from an herb or plant source. Folk medicine, naturopathy, and herbalists have become more popular as people seek alternatives to conventional, synthetic medicines. However, the products from compounding pharmacies are different in several ways. First, the medicine provided by a pharmacy requires a prescription. Health food store products are most often of a dose that is so low that it does not require a prescription. Usually the dose is so small that it is insufficient to produce a measurable difference in the body, based on laboratory tests. Second, the products from the compounding pharmacy utilize ingredients of a pure pharmaceutical grade that are micronized. Micronized means that the product is a fine grain that will be well absorbed. Third, the natural hormones from the compounding pharmacy can be prescribed as long-acting, or time release. This helps the body have a balanced hormone level instead of the highs and lows that come with quick acting, quickly absorbed or poorly absorbed products.  In order to assure adequate replacement, hormone levels are monitored and then adjusted to maintain optimal levels of all hormones. HRT might be worthless unless monitoring and adjustment is done.

​

To summarize, a bioidentical hormone has a chemical structure that is identical to the hormone naturally produced by the body. We refer to them as natural because they are natural to the human body. Natural hormones cannot be patented by drug companies. Synthetic hormones have a structure similar to but not exactly the same as a hormone produced by your body. These chemical differences mean that the synthetic hormone acts differently and produces substantially different effects. Natural (bioidentical) and synthetic hormones should not be considered the same or used interchangeably. They are entirely different. A multitude of studies have demonstrated many harmful effects of synthetic hormones whereas the medical literature supports no harmful effects of natural hormones, only beneficial effects.

​

The Synthetic Hormone Controversy:

​

Recently there has been tremendous confusion and misunderstanding concerning the article published in JAMA, July 13, 2002, concerning the use of synthetic estrogen and progestin. The following is an in-depth review of the hormone controversy and the recent medical studies involving synthetic hormones.

​

The Women’s Health Initiative (WHI) Study demonstrated that the combination synthetic hormones, Premarin and Provera or PremPro, resulted in an increased risk of breast cancer and heart disease. However, the incidence was very low at less than 1 per 1,000 women. PremPro consists of a synthetic estrogen from the urine of pregnant horses and progestin (Provera), imitation progesterone. Experts from all fields of medicine are now calling for a discontinuation of all hormone replacement based on reported increases in heart disease, breast cancer and blood clots in this WHI trial. This is an inappropriate reaction to and incorrect interpretation of one study! There are other safe hormones, which were not included in this study, that have been incorrectly targeted. The information contained in this latest study is not new news and the conclusion of this study does not apply to natural biologically identical hormones. The JAMA article specifically addresses this issue. Unfortunately, the media will take things out of context and publish misinformation. Patients then misinterpret these findings because of the media confusion. The intent of this notice is to clarify this issue and the article.

​

An article appeared in JAMA in 2000, Jan 26; 283(4):485-91, which concluded that the risk of breast cancer increased 8 times with Provera. The July 2002 article is no different. It again demonstrates what has been known for some time, that Provera increases breast cancer risk, but it has never received the media attention and medical criticism as now.

​

Even though the WHI Trial evaluated Premarin and Provera, it was finally shown that it was primarily the synthetic progestin (Provera) that was the culprit in causing the harm. In the first arm of the WHI, Premarin-Provera caused an increased risk of breast cancer and heart disease. In the second arm of the study using estrogen alone, without Provera, the results were very different. There was no increased risk of breast cancer or heart disease. In fact, there was a decreased risk of cancer and heart disease in the estrogen only group. However, most physicians and the media misinterpret the data and conclude that estrogen is harmful when in fact it is not; it is progestin (Provera) that caused the harm.

​

The other inappropriate conclusion was that all hormones in women should be stopped just because Provera is harmful. This conclusion does not apply to all hormones. All hormones should not be stopped, just the Provera. What should women take in place of Provera? The answer is simply natural progesterone. However, many physicians may claim that it makes no difference, that all hormones are the same. This is simply incorrect. The natural hormone in the body is called progesterone; the synthetic, chemically altered hormone is a progestin (Provera) and is a completely different molecule. It is not the same.

In recent studies, Provera has been shown to cause breast cancer; natural progesterone has been shown to decrease the risk of breast cancer. Provera increases breast density; progesterone decreases breast density. Provera stimulates breast tissue; Progesterone down regulates breast receptor sites. Provera raises cholesterol; progesterone lowers cholesterol. Provera is associated with a multitude of side effects. Progesterone has none. Progesterone is pro-gestational, the hormone that is necessary to maintain pregnancy. Provera is a teratogen (causes birth defects) and is absolutely contraindicated in pregnancy. These hormones absolutely are not the same. These are two completely different hormones with completely different effects.

​

The confusion stems from the generic name of Provera—medroxyprogesterone. Because the term progesterone is in the name some consider medroxyprogesterone to be the same as progesterone. As explained above, we know they are very much different, both in chemical structure and effect. As evidenced in the findings of the WHI Trials, one must understand each individual hormone. The WHI proved that the combination of Premarin and Provera was harmful. The estrogen-alone arm of the study determined that estrogen alone, without Provera, did not cause breast cancer or heart disease. (This study used Premarin as the form of estrogen. The chapter on estrogen explains the better option.) The WHI vindicated estrogen and showed Provera (progestin) to be the culprit. The safer bioidentical progesterone should be substituted in place of Provera or progestin. We should use bioidentical estrogen and bioidentical progesterone and avoid the problems associated with synthetic hormones. When our body loses hormones, it is critical for healthy aging that we put back in the same identical hormone instead of a hormone that is molecularly different.

​

The pharmaceutical companies are trying to manufacture progestins that more closely resemble the molecular structure of natural progesterone in order to avoid the side effects and complications associated with the synthetics. The pharmaceutical industry is putting considerable efforts into this development because natural progesterone is devoid of any side effects or complications. What begs for an explanation is if the natural hormone is so perfect in its lack of side effects and complications, why not simply use the natural progesterone? Again, the drug companies can’t patent or profit from a bioidentical product. However, patients sure can!

There are two recent studies indicating that natural progesterone protects against breast cancer by decreasing epithelial cell proliferation in the breasts (Fertility Sterility 1998; 69:963-69). Another study showed that progesterone was more protective than Tamoxifen, which is a treatment for breast cancer (Japan Journal of Cancer Research 1985; 76: 669-04). And another document shows decreased ductal stimulation by progesterone by 400% (Fertility Sterility 1995; 63: 785-91). There are many studies that show that Provera increases the risk of breast cancer; progesterone decreases the risk. Again, progesterone is not Provera. In the PEPI trial, it was shown that estrogen and progestin increased the risk of heart disease, whereas estrogen and natural progesterone decreased the risk of heart disease. Provera increased cholesterol and clotting whereas progesterone caused the reverse thereby Protecting the heart. This July 3, 2002, study from JAMA (WHI) essentially shows the same. It amazes me that it still comes as a surprise to the medical community that progestins increase the risk of heart disease when it has been so well documented in the literature. Provera antagonizes the beneficial effects of estrogen on coronary artery atherosclerosis (Arterioscler Thromb Vasc Biol 1997 Jan; 17(1):217-21). By now it should be apparent that not only is progesterone not the same as Provera, it is completely the opposite.

​

An article in the medical journal American Family Physician showed that Provera and progestins cause significant side effects of swelling, fluid retention, breast tenderness, bleeding, depression and mood disorder. Progesterone is devoid of these side effects; it is the feel-good hormone of pregnancy. Provera is not a feel-good hormone.

​

The recent JAMA article stated that Premarin by itself did not increase the risk of breast cancer. The National Breast Institute and the National Institute of Health have emphatically stated that there is no conclusive evidence that Premarin (estrogen) alone causes an increased risk of cancer. Overall, 75% of all the studies in the medical literature show no increased risk of breast cancer and this article from JAMA is no different- the risk is from adding the synthetic progestin (Provera). However, there are a few studies that show a slight increased risk of breast cancer with Premarin. The overall risk from these few studies is still very low, but the risk significantly increases with the addition of a progestin. In summary, most studies show no increased risk of cancer and a few studies show a very low risk if any with use of Premarin by itself. However, in my opinion, we should still not use Premarin because of the metabolites it produces which can cause many side effects.

​

Premarin contains equilin which has been reported in 2 cancer research journals to cause cancer (Chem Res Toxicol 1999 Feb;12(12(:204-13). There is ample evidence now to implicate the synthetic estrogen with a small increased risk of cancer and the synthetic progestin with the much greater risk of breast cancer and heart disease. The July 2002 JAMA article emphatically states that the concern is with the synthetic progestins and does not include other hormones nor the natural estrogen or progesterone.

​

The original intent of using the bio-identical natural hormones is to avoid the side effects and complications of the synthetics that we have known about for years. Why all the sudden media attention is not known. What needs to be clarified is that the concern should be only with the synthetic progestin, whereas the media and newspapers misquote that all hormones are damaging. The solution to the problem is the same that we have been recommending for years —natural, bio-identical estrogen, progesterone, and testosterone. The deterioration starts at menopause when our hormones decline. Avoid the harm by simply replacing our hormone levels back to the levels we enjoyed before menopause. The landmark papers that document the importance of this therapy over the problematic synthetic hormones are: Infertility and Reproductive Medicine Clinics of North America Vol 6, number 4, Oct 1995, and Obstetrics and Gynecology Clinics of North America Vol 21, number 2, June 1994.

​

The final nail in the coffin for the synthetic hormones comes with three recent European studies. The purpose of the studies was to demonstrate the difference, if any, between the synthetic hormones and natural hormones and the method of administration. The exact results were confirmed in all three studies, the largest of which consisted of 100,000 women studied for ten years. The synthetic hormones were responsible for an increased risk of breast cancer. The natural estradiol and the natural progesterone were protective and demonstrated no increased risk of cancer. This was the longest and most powerful study to date demonstrating the safety and superiority of bioidentical hormones over the problematic, side effect prone, synthetic hormones.

​

None of these new studies provide any new information to me nor does it affect the way I prescribe hormones. All of this information has been in the literature for years. Where was the media then? These recent studies are finally the eye opener for both patients and doctors to avoid the synthetic hormones and replace only those hormones that normally occur in the human body. Menopause results in a tremendous increased risk of heart disease, osteoporosis, urogenital atrophy and cerebral deterioration — all that can be prevented by simply maintaining hormone levels. And in spite of the health benefits, we should not ignore the symptomatic improvement and quality of life issues that are the primary reason to use the hormones in the first place. Just use the right hormones in the right dose and monitor the levels. I hope that this clarifies all the issues. Remember, stop synthetic hormones that are harmful. Do not stop the beneficial, biologically identical hormones.