Synthetic Hormones

Risks And Links To Cancer

Hormones are very powerful molecules. Understanding their role in our lives and the impact they have on everything we do gives me pause. Before we enter the realm of synthetic hormones and their connection with cancer, a few critical concepts must be understood.

Say you drive to work every day, and always take the same route. You pass the same houses, the same trees, the same scenery every day for years. You think you know the road like the back of your hand. Then suddenly one day you notice a yellow house on the right. It's not new, it's always been there, you just haven't noticed it before. Has this ever happened to you?

It's a common occurrence and it just reinforces that we are human and our brain, no matter how intelligent and perceptive, can only take in a limited amount of information at any given time. And then randomly, one day, the brain opens up and allows a little more information to penetrate our conscious mind.

That is exactly what happened to me with regards to natural versus synthetic hormones: as a conventional physician I believed that estrogen- the hormone our bodies makes- and synthetic estrogen substitutes were similar enough to be interchangeable. The reason for this belief comes from my education. Medical school trained me to believe that estrogen replacement for menopause consisted exclusively of synthetic hormones. Although scientific data questioning the safety and the efficacy of synthetic hormone replacement abound in the medical literature, natural hormones were not an option. It took almost a decade of private practice to bring me to the point where my mind opened up, understood, and welcomed the difference between natural and synthetic hormones.

Let's spend a little time on understanding the significance of the difference.

Estrogen

Estrogen, is a natural hormone made by the ovaries and adrenals of every human and mammal in the world. It defines certain critical female characteristics and has a wide array of effects. Until the mid 1960s the only thing doctors knew about estrogen was its effect and importance in the human body in its natural form. In 1966 Robert Wilson, a physician, published a book called Feminine Forever. Sponsored by a large pharmaceutical company that had received the patent to make a synthetic estrogen called Premarin, the book was an immense success. It appealed to women's desire to stay young and attractive as well as free of menopausal symptoms. The outcome meant more than success for the book, more than skyrocketing sales for Premarin, it was a tipping point. As a result of a successful marketing campaign Americans started to identify estrogen with Premarin. Just like we identify tissues with Kleenex, diapers with Pampers. Thus the difference between natural estrogen made by our bodies and synthetic estrogen was annihilated in the minds of the public and the medical profession as well.

While this situation created a boon for the Premarin industry, it did not help women feel better. Both physicians and women knew that Premarin was not the panacea it was billed to be, but the market did not readily offer alternatives. Without the help of conventional doctors who for the most part were totally unaware of their existence, and without mainstream scientific presence, natural hormones entered the market through the back door. As the knowledge that natural hormones produce superior clinical results, and are safe and easy to use, increasing numbers of physicians are engaging in the battle to separate the two- estrogen from Premarin!

Hopefully by the end of this chapter, I will have helped you accomplish this separation in your own mind. My success will not only give you more information, but increased knowledge and reassurance that natural estrogen has not been involved in studies connecting it to cancer. Most conflicting data on the dangers of HRT come from evaluation of synthetic hormones and not natural ones.

When I talk about estrogen, I am only referring to the hormone naturally made by our bodies, not the synthetic substitutes made in laboratories. This estrogen defines us as women, it makes our breasts grow, it brings on our periods, it makes the lining of the uterus grow, it makes us ovulate, it prepares and supports pregnancy, and the growth of the fetus inside our womb. It also protects us from heart disease, makes our bones strong and keeps our metabolism running in high gear. Mother Nature insures the perpetuation of the human species by revving up our bodies' hormone production. When we are young our bodies manufacture gallons of estrogen in order to fulfill our calling. High levels of estrogen bathe our every organ during pregnancy. These high levels of estrogen do not make us sick, as a matter of fact, they make us glow and keep us healthy. With this knowledge in mind, synthetic estrogen was developed. No pharmaceutical company would have created an estrogen-like substance (trying to duplicate the effects of the natural molecule), if estrogen had been perceived as dangerous.

When Robert Wilson's book was published in 1966, estrogen made its grand entrance as the sole hormone of importance in the well-being of women. While every endocrinology textbook stresses the equal importance of progesterone- in the maintenance of normal hormone balance in women-progesterone was not brought to the market when Premarin emerged. It was a serious oversight. The women who took Premarin in the 1960s were limited in numbers, seemed happy, and offered no complaints to their doctors.

A key point to remember was that menopause was not an openly discussed topic in those days. The woman's role was still limited to the home, having and raisins children, and women were not a major presence in the market place. The women's movement was just beginning, and its leaders were more concerned with birth control then menopause. Most women didn't even know menopause existed. Our mothers never talked about it, I never even knew my mother went through menopause and I was a doctor. I remember once hearing about the distant great-aunt who went crazy in mid-life and ended up in a mental institution, but no connection was ever made between mental or physical problems and menopause. menopause was relegated to a deep, dark secret hidden in the back of the women's closet. So without public demand, pharmaceutical companies had no motivation to look any further into the area of female hormones. Premarin stayed the only option.

By the 1970s, things started to change. Studies on Premarin started to connect Premarin therapy to an increased incidence of uterine cancer. At the same times studies on birth control pills (containing high dose synthetic estrogen as well), started to connect usage of birth control pills to increased incidence of blood clots (to the legs and lungs). The situation caused concern and prompted a flurry of search for alternatives. Although low dose estrogen birth control pills started to arrive on the market, the basic make-up of birth control pills has remained the same to this day - synthetic hormones.

At the time I was in medical school and I distinctly remember seeing patients with the side-effects of synthetic estrogens described in the scientific articles I was reading. In the clinics of Kings County Hospital, I saw women with swollen breasts, heavy irregular periods, ovarian cysts, phlebitis, and pulmonary embolisms. They were the living and breathing connections to the effects of synthetic estrogens reported in the medical literature. With all good intentions we had started these patients on synthetic hormones and suddenly were faced with outcomes we never expected. We never considered side-effects, like toxicity to sex organs that were over stimulated by synthetic and high dose estrogen replacement, meaning ovarian cysts, endometrial cancer, breast cancer, ovarian cancer. And why would we? We were still in the honeymoon period of pharmaceuticals and medicine.

But like most honeymoons, this one ended too. In many respects it created a long lasting marriage, but in others, many unanswered questions started to arise. Slowly but surely data on significant side-effects of synthetic hormones appeared in the medical and lay literature. Women started to react. Many stopped taking Premarin and many stopped taking birth control pills. Unfortunately, many stayed on the potentially dangerous medications. Some were afraid to disobey their doctors. Many were scared to even tell their doctors of problems they were having with the medications, and some just ignored the side-effects and made them part of their lives.

Others with the guidance of a few then revolutionary physicians, turned to the forgotten hormone- progesterone for help with hormone balance and protection from estrogen dominance and its now well-documented dangers. At that time there was no mass produced progesterone on the market.

Progesterone

Pharmaceutical companies did not waste any time cashing in on the need for progesterone. But just like with Estrogen, in order to get an uncontested market share, progesterone had to be patented and thus made to be a synthetic molecule. (However, as we learned in Chapter 6, you cannot patent naturally occurring substances. The only way to make money is to have a patent. The only way to get a patent is to make a substance that isn't natural, is synthetic). Enter progestin. Progestin as in Provera, PremPro and Premphase became the solution to the problems Premarin could not solve. But progestin is not progesterone and that is another source of confusion to the public. Both doctors and patients had now lost the battle to separate synthetic from natural hormones. With the arrival of synthetic progesterone, the market was flooded with the success of the two synthetic preparations and the natural hormone option did not even appear to exist.

Before we go on, I have compiled a list of synthetic hormone preparations available on the market, which every reader should study. Become familiar with the names and be aware that the results of the studies I will quote in the rest of this chapter usually reflect outcomes from the use of these medications.

Synthetic Estrogen

Premarin (pills)- Conjugated horse estrogen
Menest (pills)
Estratab (pills)
Ogen (pills or cream)
Ortho-Est (pills)

Synthetic Progestins

Amen (pills)
Aygestin ( pills)
Curretab (pills)
Cycrin (pills)
Depo- Provera- Medroxyprogesterone Acetate (injectable)
Norlutate (pills)
Provera (pills)

Synthetic Estrogen And Progestin Combinations

Estratest (pills)
Estratest HS (pills)

Birth Control Pills

All of the above are hormone impostors, they are synthetically manufactured to fool our bodies into believing that we are getting the hormones we need. But unfortunately, synthetic hormones cannot fool our bodies and ultimately we may pay a high price for using them. Let's go back to Premarin and Provera (progestin)- the prototype of synthetic hormones. In our bodies, they accomplish three goals, none of which we really need for healthy function:

They replace and inactivate whatever hormones our bodies are producing by taking up receptor sites, thus diminishing the usefulness of circulating natural hormones.
They replace your healthy human hormones with synthetic substitutes.
They create new receptors for the foreign molecules on our cells. This confuses the cells and stimulates a defensive immune response.

When synthetic hormone replacement became popular in the mid 60s- the long term effects could not be anticipated, but many tell-tale signs of their incompatibility with the human body were recognized immediately. Unfortunately, most women taking them either ignored their side-effects, or went off the medications and never shared important information about the medications' short-comings with their doctors.

I remember distinctly feeling very sick the first month I took birth control pills at the age of 19. I was placed on them because I had severe menstrual cramps. My doctor told me to bear with it because they would eliminate my cramps and as an added bonus I would be protected from getting pregnant. I was not sexually active. All I started with was bad cramps. Within three weeks I had migraines, became bloated and moody and felt like I was living in another person's body. I called my doctor and asked if my new symptoms could have anything to do with the birth control pills. He told me it was very unlikely. I stopped taking birth control pills after two months. I never went back to that doctor. I also never called him to tell him why. He may still be prescribing medications and thinking the patients are taking them, even if they are not. I should have called to tell him, I night have helped both him and other women.

When I started practicing medicine, I listened to the same story from many of my healthy young women who were taking birth control pills. When they complained of headaches I gave them medication, when they became bloated I gave them some more medication. It took many years to connect the medication to the problems. Today, if a young woman has side effects from birth control pills, I advise her to discontinue the pill and use other methods of contraception. As a rule, if a woman reacts with significant side effects to one type of birth control pill, her chances of better tolerating another, are minimal. I don't like to suggest any synthetic hormones for birth control any longer. Long term effects of birth control pills on fertility, cancer, and early induction of menopause, have not been addressed. The medical literature offers no research, no data, and no reassurance about birth control pills. It is odd that no studies are being published on the long term effects of birth control pills, when they are the number one method of pharmaceutical contraception today. On the other hand, data on the use of natural hormones for birth control is slowly percolating and the results appear promising. In my practice we use natural hormones successfully in women over 40. Although we often combine natural hormones with diaphragms and IUDs, our patients are happy and free of side-effects.

Let's go back to synthetic estrogens beyond childbearing age and take a closer look. Premarin, the quintessential synthetic estrogen, when placed into the human body acts like estrogen in one important respect. It makes breast and endometrium tissue grow. The only difference from human estrogen is that it is synthetic and thus toxic to our bodies. Equinil, the horse specific estrogen, is a molecule foreign to our bodies. When it attaches to our cellular receptors, our immune system tries to fight it off. The normal body means of defending from foreign molecules (horse protein in this case) is to insulate them by building walls around them or creating a systemic immune response. The wall may be a tumor or an abscess, the immune response- allergies, migraines, rashes. On a cellular level, the reaction is even more dramatic. Two scientific studies published in 1998 and 1999 in Chemical Research in Toxicology and Proceedings of the Society for Biological Medicine, proved without question that equilin once broken down in our bodies becomes toxic to the very DNA that keeps us healthy or makes us sick. The above information followed a cover article in Time magazine in 1995 called The

Estrogen Dilemma. For me and my practice, the information introduced and the questions raised were sufficient to provide the final nail in the coffin. I would never prescribe Premarin again. The risk was too high, the rewards too low. Suddenly, all the side-effects, the questions and the doubts I had about Premarin became too overwhelming to continue prescribing the medication. It became an ethical concern for me.

Endometrial and Uterine Cancer

Estrogen causes the lining of the uterus to grow in normal women. Progesterone is the only help our body has to prevent unchecked growth stimulated by estrogen. Progesterone balances estrogen by turning off the cell growth mechanism. It makes cells stop growing. Thus it prevents overgrowth of the lining of the uterus- aka endometrium. Normal women seldom if ever get uterine cancer. This disease was brought to us largely through the treatment of menopausal symptoms with synthetic estrogens.

Between the 1960s when Premarin came to the market and the 1970s when the data on endometrial cancer started to appear in the medical literature, more and more women were treated with Premarin alone without the invaluable balancing effect of progesterone.

The Endometrial Cancer Cooperative Group established the relation between estrogen replacement and the risk of endometrial cancer. The results of their studies showed that women who took synthetic estrogen for one to five years had a three fold increase in incidence of uterine cancer. Those who took synthetic estrogen for ten years, had a ten fold increase. Lifetime use of synthetic estrogen potentially increased a woman's chance of getting uterine cancer to one in ten.

Even though when I went through my medical training in the mid to late 1970s unopposed synthetic estrogen therapy for menopausal symptoms was loosing appeal, all too many women were still treated with synthetic estrogens without balancing them with progesterone. I remember being taught that although the incidence of deaths from uterine cancer had increased two to three fold in the years since Premarin, uterine cancer was a low grade cancer. A 1993 study by the Endometrial Cancer Collaborative Group published in Unresolved Issues found that uterine cancer caused by treatment with Premarin, had a 90% cure rate as compared to uterine cancer in general, with a cure rate of only 70-75%. This may sound good to a statistician but it sounded plain wrong to me. I went into medicine to take care of patients not statistics. My professors of obstetrics and gynecology were quick to point out that as soon as we figured out the need to balance estrogen- (synthetic estrogen), with progestin (synthetic progesterone), the risk of developing uterine cancer was practically eliminated. It was just common sense. Unfortunately they were right in theory, but in practice we were not balancing with progesterone, we were balancing with another synthetic substance.

As a young doctor desperately wanting to help my patients and believing in the system that educated me, I took the information to heart and started every menopausal patient I saw on the new combination Prempro, Premphase or cycled Premarin and Provera.

But, as a measure of caution, I did make sure these women were followed with ultrasounds of their uterus on a twice a year basis. For me, a young resident in 1977, that worked and seemed safe. Premarin took away the hot flashes and Provera made women feel young because they were always having their period. I thought that was good, I was in my twenties and did not know that fifty-five year olds do not need to have a period.

In 1994 a landmark study was published in the American Journal of Obstetrics and Gynecology by JD Woodruff and JH Pickar. It addressed the "Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (synthetic) with Medroxyprogesterone acetate or conjugated estrogens alone." This article addressed the results of an extensive study on the effects of four different regimens of combinations of synthetic estrogen and progestin and synthetic estrogen alone, on the lining of the uterus. The duration of the study was one year and it involved approximately 1000 women. The results clearly established that treating women with synthetic estrogen alone, highly increased the risk of endometrial disease, while combinations of synthetic estrogen with synthetic progesterone offered some protection.

Since that time other studies have validated the findings described in the JD Woodruff study as well. While factually the information gathered from these studies is true- unopposed estrogen therapy increases the risk of uterine cancer- no natural solution is offered. All these studies address use of synthetic hormones.

To provide a realistic picture of the effects of hormone therapy, combinations of natural estrogens and progesterones must also be included. Unfortunately, they are not. Since the studies are costly, they need financial support and the medications are supplied free of charge by the manufacturers of synthetic hormones. Natural hormones are not included. The situation leaves a very important question unanswered: Is the increased rate of endometrial cancer caused by estrogen in general or by synthetic estrogen in particular? Commonsense warns even the least scientifically oriented of people, that synthetic substances could potentially be harmful and if you can get the same thing in natural form then it must be a better option.

These studies, although incomplete because they only address results of synthetic hormone therapy, did appear to provide comfort to us doctors. Prolonged use of unopposed estrogen can cause uterine cancer, while the combination of synthetic estrogen and progestin eliminates the risk. So, doctors continued to write prescriptions for synthetic hormones.

Let's not forget another piece of information the research found - estrogen, the hormone made by our body, has practically no connection with endometrial cancer. The average woman who has never taken hormone replacements, rarely, if ever, gets endometrial cancer. It occurs in less than 1 in 1,000 women each year- American Journal of Obstetrics and Gynecology -1998. (NB. This number is based only on information obtained from women who have pelvic examinations, less than 10 % of women do.) When evaluating the data, let us note that natural hormones, are similar to our own, are milder in their effect, and due to the flexibility of dosing, provide less risk and more protection from the dangers of synthetic hormones.

Ovarian cancer

On March 21, 2001 the Journal of the American Medical Association reported on a 15 year study conducted by the American Cancer Society. The study determined that women who took estrogen replacement for more than ten years between 1982-1996 were at double the normal risk of dying from ovarian cancer.

Within 48 hours of its publication, the data reviewed by academic medical centers and the media, was deemed statistically insignificant, and the study flawed. Unfortunately, the information albeit rapidly discarded, raised another question about the dangers of synthetic estrogen replacement therapy.

LouAnn died of ovarian cancer at 46 in 1996. She was single, had no children and had been taking PremPro for fifteen years because of family history of osteoporosis and heart disease. When she became my patient, she had already been diagnosed with ovarian cancer and had undergone surgery and chemotherapy. They did not work. I provided more hospice care for her than medical care. Sadly, I watched her wither away and die without much more than kindness to offer. After the publication of the ovarian cancer study in 2001, I could not help but wonder about LouAnn. Yes, she was at high risk of getting ovarian cancer because she had no children. But, who could really tell if in fact it wasn't the fifteen years of synthetic estrogen that pushed her over the edge? For me, it was another strike against synthetic estrogen replacement therapy.

Breast Cancer

Although 80% of women who get breast cancer have no common risk factors, contributory factors, genetic or environmental, must be seriously taken into consideration. Breast cancer is a hormone dependent cancer. High levels of unopposed estrogens increase the woman's chances of getting breast cancer. We are exposed to too much estrogen when it is out of balance with progesterone, when we are exposed to chemicals and phytoestrogens, radiation, or when we are receiving it in the form of synthetic estrogen replacement therapy.

In 1990, an article entitled "The Endocrinology of Breast Cancer" published in Cancer, established the clear connection between unopposed estrogen and the development of breast cancer. Since then, studies on synthetic estrogens have only increased the panic women experience living in constant fear of breast cancer. Even though breast cancer is not the number one killer of women, its connection to hormone replacement therapy has become the main deterrent in the use of HRT. Unfortunately, the fact that natural progesterone and estrogens offer protection from the danger of breast cancer, has been overshadowed by the negative publicity received by their synthetic counterparts.

JAMA- 1977, Cancer Research- 1973, Lancet- 1980, all reputable and highly respected medical journals, published numerous articles on the beneficial anti-cancer effects offered by estriol (natural estrogen). Unfortunately, no large scale follow-up studies have been undertaken on behalf of the value of natural hormones since their initial publications more than twenty years ago. The obvious reason: no sponsorship by pharmaceutical companies, no incentive to study them further.

Race differences and country of residence are significant. Caucasian Americans over the age of 45 are most likely to be diagnosed with breast cancer. This is purely a function of statistics. Aging American women of middle to higher socio-economic levels have more mammograms, more regular check-ups, and are targeted by the media for all types of breast cancer awareness activities. In African American women breast cancer is rarer with a poorer prognosis and earlier peak of incidence. The types of breast cancer African American women develop is highly virulent and occurs in younger women. The criteria used to diagnose breast cancer in Caucasian women does not apply. Research on breast cancer in African American women is largely inexistent. Asian women are considered the gold standard. They have a very low incidence of breast cancer and our scientists are in constant debate over the reasons why. Genetics are an obvious factor, but proponents of the miracle of soy have claimed its omnipresence in the diet to be a factor. To date the jury is out and the research should be directed at the women with high incidence of cancer and their protection.
Family history of breast cancer. BRCA (Breast Cancer) 1 and 2 genes account for 80% of inherited cancer cases. Other genes including H-ras, P53 account for the rest of genetically inherited breast cancers. It is important to realize that more than 40% of women with these genetic mutations do not get cancer by the age of 70. BRCA genes, in the rare instances they are expressed, are associated with breast, ovarian, and colon cancer in women, and prostate, and colon cancer, in men. Jews of Eastern European origin carry these genes at a 2.3% rate. The population at large has less than 0.003% chance of carrying these genes. An internet group called FORCE, provides important communication and support for women carrying these genes.
Personal history of breast cancer. Women who have had breast cancer have a fivefold chance of getting breast cancer again in the opposite breast or the same breast. Having a history of breast biopsies also increases the incidence of breast cancer. Scar tissue is formed at the site of the biopsy and the risk of developing cancer in scar tissue has been under investigation by the surgical researchers for years. Blind biopsies used to be the norm for evaluation of fibrocystic breasts. Although no connection was ever made between fibrocystic breasts and cancer, to this day it is not unusual to hear about doctors just doing a needle biopsy in their office, to quickly get some fluid out and diagnose the content of the mass. In my opinion, no woman should ever allow a doctor to blindly perform an aspiration biopsy. The only acceptable method of evaluating breast masses is the stereotactic biopsy procedure (see Chapter 8).
Environmental factors. Chemicals are part of our lives: exposure to PCBs (polychlorinated biphenols) in our rivers, DDT (insecticide) sprays, DES (diethylstilbestrol), and other hormones fed to our farm animals, high electricity lines in our backyards, are undoubtedly contributing factors to clusters of breast cancer outbreaks.
Women on high animal fat diets. Women of Western European and American descents where high intake of animal fat is a common staple are at higher risk. These women produce more estrogen (estrogen made in fat cells) than women whose diet is mostly vegetable and grain. The statistical difference for the incidence of breast cancer is significant. These women are without a doubt at higher risk if in addition we place them on synthetic estrogens and progestins. But to date we have no method of measuring the risk and warning them. My approach to them is to encourage women to change their diets to high fiber, low animal fat, make sure they do not smoke and supplement them with low dose estradiol and micronized progesterone.

Before I conclude on the topic of breast cancer I want to bring in another related topic- the use of designer estrogens or anti-estrogen drugs.

Designer Estrogens - SERMs

SERMs- Selective Estrogen Receptor Modulators, are a new group of drugs. SERMs compete with human estrogen for specific sites on cell receptors. They are synthetic and designed to replace estrogen in certain tissues. They bind to Estrogen alpha and Estrogen beta receptors and together they form a complex structure with divergent effects on human organs.

On uterus and bones, the complex has estrogen-like effects, but on breast tissue it has an anti-estrogen effect. The reasons SERMs were developed was to counteract the negative effects of Premarin. SERMs were supposed to protect women from increased risk of breast cancer and endometrial cancer.

The two most commonly used are raloxifene ( trade name Evista) and tamoxifen (trade name Nolvadex). A special report published in March 2001 in the journal Postgraduate Medicine through a grant of Merck &Co. Inc, provides an overview on The Effects of SERMs on Women's Health. The report raises questions of safety of use, risk-benefit ratio and overall increases of dangerous side-effects.

Tamoxifen

The National Surgical Adjuvant Breast and Bowel P-1 trial regarding tamoxifen therapy for breast cancer concluded that:

Tamoxifen significantly decreased the relative risk of breast cancer by 49%.
Follow-up on tamoxifen's impact on overall mortality was not available. The authors of the study strongly recommended it be made available.
Trial results do no apply to the population at large.
Tamoxifen was not recommended for the prevention of osteoporosis. Women over the age of 50- who are most likely affected by breast cancer had more adverse effects.
The benefits did not outweigh the adverse effects.

And yet, 10,000,000 women are on tamoxifen. Tamoxifen is prescribed for a minimum of five years in women who have had breast cancer. Tamoxifen is prescribed prophylactically as well. This treatment is based on the results of a National Cancer Institute study which has been questioned repeatedly by English and Italian scientists in articles published in the medical journal Lancet.

In my opinion, this drug should not be used on women with breast cancer or even worse, as an option for hormone replacement. Nor should it be used to prevent breast cancer in women at risk. Tamoxifen causes a 2.5 to 7.5 increase in incidence of uterine cancer. The types of uterine cancers associated with tamoxifen are more aggressive than any other. Tamoxifen is associated with increased incidence of blood clots, thrombophlebitis, and pulmonary emboli. Tamoxifen induces early menopause and all its symptoms. Women on tamoxifen often gain weight, develop severe night sweats, hot flashes, thinning bones and heart disease.

As more negative data appear in the literature on tamoxifen, estrogen and progesterone are being reintroduced in the formula for women who have had breast cancer. Once considered taboo, placing women on hormones after breast cancer appears to be safe and even prevent the cancer's recurrence. Proponents of natural hormones have been saying this for years and successfully treating women with natural hormones without recurrences or untoward symptoms.

Raloxifene

Raloxifene is another potentially disastrous new designer drug with far reaching medical implications. Its chemical make-up is very much similar to Tamoxifen.

Raloxifene was initially developed to treat breast cancer as well. When during its trials, it failed to produce a good therapeutic response in women who had tamoxifen-resistant breast cancer, it was re-routed as an estrogen-like drug for the treatment of osteoporosis.

A study by Delmas and Ettinger concluded that Raloxifene was effective in both prevention and treatment of postmenopausal osteoporosis and the FDA approved its use for those indications. Another role for Raloxifene was found in its decrease of LDL cholesterol levels. This prompted a study in progress (RUTH) Raloxifene Use for the Heart. Its results will be available in 2007. Another study (MORE) Multiple Outcomes of Raloxifene Evaluation provided the following results:

Raloxifene significantly decreased the relative risk of breast cancer by 76% in the population studied
Raloxifene increased the risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis 3:1
Performance on cognitive function tests was not improved
LDL cholesterol was decreased, but HDL (good cholesterol) was not increased
Bone mineral density was increased but only minimally

Side-effects include hot flashes, night sweats and bloating. So far, it has proven to be of no help for treating hot flashes, improving good cholesterol or preventing heart disease or preventing Alzheimer's.

Toremifene and Droloxifene

Structurally related to tamoxifen these are the newest SERMs to hit the market. All the data about them are theoretical. They have no track record and their synthetic make-up has scared away even the staunchest supporters of synthetic hormone replacement. I absolutely would not recommend them to my patients.

All studies that connect the use of estrogen to cancer refer to the usage of synthetic estrogens. Within that framework, the only statistically significant connection between use of synthetic estrogens and cancer exists between the use of unopposed synthetic estrogens and uterine cancer. Reassuring information comes to us from studies which reveal that the combination of even synthetic estrogens with synthetic progesterones- progestins, provide protection from uterine cancer. Based on the data presently available in the medical literature, natural hormones are needed to help provide protection from damage by unopposed estrogen, by genetic and environmental factors linked to reproductive cancers. As the public understanding and need for natural hormones rises, clinical studies started in the 1970s and 1980s will resurface and be developed in the conventional medical literature. This will increase physician awareness as well as the use of natural hormones not only in the treatment of symptoms of hormone deficiency, but also in the prevention of cancer.

Read on to find out more about Synthetic Hormones