Bioidentical Hormone Replacement Therapy

Hormones are some of the most powerful molecules in our bodies. We cannot survive without them. And yet, many adults are living in a state of depleted hormones, due to stress, toxicity, and natural aging. From an evolutionary perspective, we were only expected to have a lifespan of 30 - 40 years, so that is the age at which hormones naturally start to decline. However, today, we are living much longer, and have many chronic diseases that many in the alternative health field believe are directly related to the loss of our natural hormone balance.

Both men and women produce exactly the same hormones, but in different amounts – which means that men need progesterone and estrogen, and women also need testosterone.

The goal in BHRT is to replace the most important hormones in our bodies to levels that would be expected in a healthy young adult, before most people develop chronic illnesses. There are many in the traditional medical arena that disagree with replacing hormones in older adults, and even some who say it isn’t “natural” to do so. But our bodies were designed to live in balance with all of the important hormones available to us, and I believe that we are lucky today to be able to replace them to youthful levels if we choose.

Hormones are very specific, and it is important to have an amount that is “just right” – not too much, and not too little. It is never good to try to take more than your body needs. For instance, body builders that take anabolic steroids to try to build an un-natural degree of muscle suffer serious negative side-effects from taking hormones in massive doses. Our goal is simply to be optimally healthy, so only the amount that makes the patient feel their best is prescribed.

There is also a strongly-held belief in much of the traditional medical community that hormones can cause cancer and other serious illnesses, so they feel that it is dangerous to prescribe them. However, most of the major studies that have been done on hormones that showed that they were dangerous were done using FAKE hormones. Fake hormones are definitely bad for you and should never be taken if at all possible. Fake hormones do cause illnesses such as cancer and should be avoided.

Some may ask why bioidentical hormone replacement therapy isn’t more widespread, and more accepted by the medical community. One of the most important reasons for this is that drug companies cannot patent bioidentical hormones, and therefore cannot make a big profit off of them. Drug companies largely control the medical education of doctors, so most doctors have not been educated about the important health benefits of this treatment. Only doctors who go to special medical education conferences will learn about this important therapy.

Many studies have shown that bioidentical hormones actually protect patients from diseases such as cancer, diabetes, heart disease, and many of the other chronic diseases that plague our society. However, old attitudes die hard, and many doctors are still misinformed about this cutting-edge treatment. It is very important for patients to educate themselves about BHRT. There are now many books on this subject. I recommend that every patient read several books on the recommended reading list to familiarize themselves with the issues involved with BHRT, so that they will be able to discuss it intelligently with their other doctors and friends and family.

Hormones for Women

In pre-menopausal women, estrogen is made in the ovaries. A reproductive woman makes estrogen every day of the month. Estrogen is a very powerful hormone, and affects many tissues in the body, including the brain, liver, bones, skin, uterus, urinary tact, breasts, and blood vessels. Its main job in fertility is to build up the lining of the uterus, so that a fertilized egg can implant. In the brain, mood, memory, and feeling strong and motivated in life all depend on adequate estrogen. In women, estrogen protects us against heart disease, stroke, osteoporosis, decreases risk of colon cancer, and decreases risk of Alzheimer’s disease and other memory disorders. It also protects against vaginal atrophy (thinning of the skin), urinary leakage (incontinence) and prevents symptoms of menopause including hot flashes. Estrogen also improves balance by improving the visual part of the brain. Bioidentical estrogen in normal physiological doses seems to be a powerful inhibitor of excitotoxicity in the brain, which may explain its protective effect in Alzheimer’s disease.

There are three different kinds of estrogen in women: Estriol (E3), Estradiol (E2), and Estrone (E1). All three have different effects. Estradiol is the main estrogen that women have when they are premenopausal, and is good for your brain and many other organs. Estriol may be the safest as far as breast protection , but is not as brain protective. Estrone is the main estrogen found in post-menopausal women, and is made in fat cells and the adrenals. E1 decreases the metabolic rate, and it is not clear if it has any therapeutic effects.

In periods of low stress, estrogen requirements go down. Under high stress, or high amounts of exercise, estrogen requirements go up. If estrogen is given without balancing hormones such as progesterone, then uterine and breast cancer risk is increased. When estrogen levels go down in menopause, sometimes Testosterone levels go up. If your periods are too heavy, it may be because of estrogen dominance. Estrogen dominance does not mean that you necessarily have too much estrogen. It usually means you don’t have enough progesterone. You will need to adjust the dose depending on how you are feeling.

In the normal menstrual cycle, estrogen is dominant the first two weeks. Estrogen stimulates growth. Progesterone should be dominant the second two weeks. Progesterone stimulates development and slows growth. These two hormones balance each other, so it is always important to have the right balance between them.

Synthetic or non-bioidentical estrogens have been found to cause health problems, including increased risk of breast cancer, heart disease, and stroke. These compounds include Premarin, Prempro, and others. Premarin comes from the urine of a pregnant horse – a substance that nature never intended to be in a human body. It has sometimes been called “natural”, but it is not biologically identical to human estrogen.

Symptoms of estrogen deficiency include:  Thinning and weakening of the bladder and vaginal walls, vaginal dryness, accidental urine loss, thin and sagging skin and/or breasts, increased facial wrinkles, itching, sweating, decreased or missing periods, hot flashes, decreased energy, fatigue, unexplained weight gain, heart palpitations, being more prone to bladder infections, depression, mood swings, decreased libido (sex drive), insomnia (interrupted sleep), and foggy thinking.

Symptoms of excess estrogen include:  breast tenderness, fibrocystic breasts, water retention, bloating, fatigue, headaches, fibroids, increased risk of breast cancer, heavy periods, low thyroid, and increased risk of endometriosis. Estrogen can increase clotting risk factors in susceptible people.

Breast cancer has many causes – toxins (such as heavy metals and chemicals), lack of important nutrients (such as folate), genetic risk factors, and hormone imbalance. Toxins such as pesticides and plastics are endocrine disrupters, and can mimic estrogen in the body, leading to an imbalance that can predispose to cancer. It is possible that women with a strong family history of estrogen-sensitive breast cancer, or a past history of breast cancer themselves should not supplement estrogen, but there are exceptions even in these high-risk populations. There are conflicting studies in the published medical literature about the long-term safety of taking bioidentical estrogen and other hormones. There are more long-term studies in Europe than there are here in the US, but this issue is not fully resolved.

Natural bioidentical Progesterone is an important hormone for both men and women. It is the first hormone to decline with age, starting to decline by the mid 30’s, and is almost zero in most people by the age of 45. Progesterone protects against breast cancer, and is very important for balancing estrogen. Progesterone is neuroprotective, anti-inflammatory, helps with anxiety and sleep, and can even help with PMS. Progesterone given immediately after a traumatic brain injury helps calm the initial cytotoxic inflammatory cascade, and results in less brain damage. Progesterone helps with many menopausal symptoms, endometriosis, ovarian cysts and cancer, lost libido, dysmenorrhea, and PMS. It is also great for mood enhancement, blood sugar support, fluid and electrolyte balance, and stress management. Progesterone can be taken as a cream, an oral pill, or as a suppository. It is great for the facial skin and breast health and it enhances collagen production and keeps skin smooth and tight.  Progesterone helps re-myelinate nerve cells, and has been found to be helpful in MS. It helps prevent osteoporosis, and reduces the level of insulin, which can cause excess fat accumulation. Progesterone is a “feel-good” hormone, and has natural anti-depressant effects. It helps with symptoms of fibromyalgia, and has even been found to be helpful in ADD symptoms induced by hypoglycemia. It helps prevent migraines, and afternoon fatigue. In fertility, progesterone helps prevent miscarriages, and stops morning-sickness.

The World Health Initiative study used Progestins (such as Provera) - not actual progesterone. Depo-provera causes osteoporosis. Progestin is a fake progesterone substitute made by a drug company. These compounds have been found to be toxic and should be avoided. Bioidentical progesterone in the form of a Prometrium 100 mg pill can be taken, but it is mixed with peanut oil, which can cause allergies in some.

Progesterone should ideally be measured in the blood on day 21 of a woman’s period, if she is still having periods. It can be measured at any time after periods stop.

Progesterone can help with the following types of symptoms:  Acne, allergic rhinitis, appetite disturbances, asthma, osteoporosis, breast tenderness, fibrocystic breasts, breast cancer, spontaneous bruising, capillary fragility, conjunctival and retinal hemorrhages, constipation, colicky pains, hemorrhoids, depression, edema, epilepsy, vertigo, fainting, glaucoma, headaches, hypoglycemia, insomnia, difficulty getting up after enough sleep, irritability, joint and muscle pains, lethargy, clumsiness, palpitations, paresthesias of the hands or feet, skin disorders, facial pigmentation, erythema, urticaria, and varicose veins.

Perimenopause is associated with high levels of Estradiol, and low levels of progesterone (low Pg/E2 ratio). This leads to excessive estrogen-stimulated proliferation of the uterus and breasts and increased risk for cancers in these tissues. Taking adequate progesterone counteracts these risks.

Progesterone side-effects: can occasionally cause acne, rare allergic reaction with nausea and weakness, can change the nature of the period – earlier or later, longer or shorter, lighter or heavier. Patients may need to redose every 15 minutes for one hour for difficult hot flashes. Discontinue any synthetic progestins. Progesterone does not increase clotting risk factors, as estrogen can.

Each patient must educate herself, weigh the possible risks and benefits, and decide for herself how she wants to proceed in managing her health for healthy aging. There are alternatives to taking BHRT, such as some herbal compounds that can temporarily ease the symptoms of hormone loss, but these do not provide the long-term benefits for the brain, bones and other organs, or provide the overall increase in quality of life that BHRT usually can.

Dr. Sangeeta Pati speaks at the American Academy of Anti-Aging Medicine (video)
http://www.worldhealth.net/pages/dr_pati_bio-identical_hormone_replacemen

Below, Dr. Pati also discusses bio-identical hormone replacement therapy as it was presented on the Oprah TV show*:

Logic dictates that human identical, bio-identical products are the only acceptable products when we are restoring hormones or nutrients. Why use a product that acts like the real thing when you can get the real thing? Oprah's show brings to the forefront of discussion the real need to help women (and I should add men) who suffer from symptoms and the real need for people to continue their quest for better health and options. 

I would like to comment on three issues that came up during Oprah's recent show on hormone replacement therapy:

1. Risk in women? When women consider hormone replacement, the looming question is about the risks, especially of breast cancer, strokes and heart attacks.  On review, women are the most protected during their 30's when they have the highest (balanced) hormone levels. It is only after menopause that women have increased risk of stroke, heart attack and breast cancer. Data suggests that it is hormone imbalances that contribute to breast cancer. We know that, most breast cancers occur after menopause; precisely at the time when the ovaries stop producing the normal balance of hormones.

Why? First, progesterone, which prevents breast cell division, declines beginning in one's late 30's. Second, approximately 10 years later comes an imbalance of the estrogens. Estriol (E3), which is breast and clot protective, decreases from 80% to 10%. Estrone (E1), which is breast and clot stimulating, goes up from 10% to 80%. The increased E1 is undesirable as E1 is converted to forms of estrogen (i.e. 16-OH E1) which are carcinogenic to the breast. So, restoration of protective hormone levels needs to be considered a possible preventative step against breast cancer.

 Large studies so far have used synthetic hormones (not identical to human hormones) with a ratio of estrogen weighted towards E1 like the large Women's Health Initiative (WHI) study published in 2002, which was followed by much confusion. Reanalysis of this study and many others has eventually led to the following three solid conclusions on hormone restoration in women.

1. When started within 10 years of menopause, hormones are protective to the heart and brain.
2. "Progestins" (not identical to bio-identical progesterone) have been shown to increase clots and breast cancer in 5 trials compared with natural "progesterone" which is associated with protection.
3. Bio-identical Estradiol (E2) delivered through the skin has been shown to decrease clots and risk of stroke and heart attacks, as opposed to E1, delivered through the mouth (i.e. Oral Premarin^TM used in WHI) which increases clot heart attack and stroke risk because of the first pass through the liver which makes clotting factors.

So, when restoring hormones, we aim to use protective forms (E2, E3) and protective delivery routes (transdermal). We aim for protective levels for the heart, brain, bone, skin and organs by measuring levels.

2. Not enough long term studies on bio-identical hormones? This was stated a few times during Oprah's show. First, nature gave us these hormones and when they are balanced in our 20's and 30's we are most protected. Second, the FDA has over 20 bio-identical hormone products approved and on the market such as Climara® patch, Vivelle® dot, Evamist® spray, and Prometrium® capsules (progesterone). Each one of these products has been studied extensively, enough to get FDA approval.  There is a very good reason why pharmaceutical companies are currently busy developing new "bio-identical" hormone products at an increasing pace. They can not patent the hormone, since it is a natural product, however they patent the delivery systems (i.e.  patch, dot, spray, gel). We should ask ourselves why they are not patenting the "other" hormone products.

3. The compounding pharmacy. There is no need to be on one extreme end with the position that there is no role for compounding or on the other extreme end where there is no role for the pharmaceutical. At times one needs a 25 mg dose of progesterone, which is only available at the compounding pharmacy. At times one needs 100 mg of progesterone, which is available at CVS® and Walgreens®. At times one needs Estradiol at .05 mcg available as Climara patch at CVS and Walgreens.  At times one needs a lower dose available compounded. I use both, depending on what suits the patient best.

When choosing a compounding pharmacy check  credentials, certifications, quality checks, sterility processes and membership in PCCA and other national organizations that assess their quality standards and adherence to the principles of compounding medicine. 

 In conclusion: With the knowledge that we will live longer than those before us, comes the quest to live better than those before us. Will we be in a wheel chair with scarce recollection of our past? Or will we be walking, talking, energetic and happy?

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*Dr. Pati is Medical Director, SaJune Medical Center, Orlando, Florida.  This article was published in the February 2009 A4M newsletter.  

Hormones and Libido

Over 70% of women with low libido have a hormone imbalance. This is a paper about libido in natural and surgical menopause. The paper is open access, so go to the website below, click on “Women’s Health”, May 2006, Vol 2, No 3, and scroll down to find the paper. Below is the abstract and authors.

http://www.futuremedicine.com/doi/full/10.2217/17455057.2.3.459

Women's Health

May 2006, Vol. 2, No. 3, Pages 459-477

Testosterone and libido in surgically and naturally menopausal women

Jeanne L Alexander 1, Lorraine Dennerstein 2, Henry Burger 3 & Alessandra Graziottin 4,5,6

1Kaiser Permanente Medical Group of Northern California Psychiatry Women’s Health, Kaiser Permanente Medical Group, 1700 Shattuck Avenue, Suite 329, Berkeley, CA 94709, USA. This e-mail address is being protected from spambots. You need JavaScript enabled to view it 2Office for Gender and Health, Department of Psychiatry, The University of Melbourne, 4th Floor, 766 Elizabeth Street, Melbourne, VIC 3010, Australia. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

3Prince Henry's Institute of Medical Research, Monash Medical Center, Clayton, VIC, Australia. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

4Center of Gynecology and Medical Sexology, Hospital San Raffaele Resnati, Milan, Italy

5Department of Obstetric and Gynecology, University of Florence and Parma, Italy

6Post-graduate Course in Sexual Medicine, University of Florence, Italy.

† Author for correspondence

Abstract:

The assessment and then treatment of a change in libido, or a change in the desire to partake in sexual activity, during the menopausal transition and beyond has been a challenging and elusive area of clinical research. This is partly due to the multidimensional nature of female sexuality, the difficulties of measuring testosterone in women in a reliable and accurate manner, and the complexity of the neurobiology and neurobehavior of female sexual desire. In addition, there is a lack of evidence for diagnostic specificity of low free testosterone levels for the symptom of low libido in women for whom there are no confounding interpersonal or psychological factors; although, in the symptomatic population of surgically or naturally menopausal women, a low level of free testosterone often accompanies a complaint of reduced desire/libido. The randomized clinical trial research on testosterone replacement for naturally and/or surgically menopausal women with sexual dysfunction has been criticized for a high placebo response rate, supraphysiological replacement levels of testosterone, the perception of modest clinical outcome when measuring objective data such as the frequency of sexual intercourse relative to placebo, and the unknown safety of long-term testosterone replacement in the estrogen-replete surgically or naturally menopausal woman. A careful review of current evidence from randomized, controlled trials lends support to the value of the replacement of testosterone in the estrogen-replete menopausal woman for whom libido and desire has declined. The issue of long-term safety remains to be answered.

Hormones for Men

Testosterone (T) Replacement for Men  Andropause, or "male menopause," is the gradual decline in male hormones with age, and has been called a fatal disease. Drops in testosterone levels begin in men after the age of about 35, and become pronounced in many men by the age of 45-50. While this is happening, Estradiol is rising, and progesterone and many other hormones are also declining. Optimal levels of T are usually what would be expected for a man in about his early 30’s. Before doing T replacement therapy, it is essential to assess a baseline level through a simple blood test. Only men who are deficient in T or have sub-optimal levels will be treated at Optimal Health Spectrums. Symptoms that may indicate a need for bioidentical hormones Do you have trouble achieving and/or sustaining an erection? Do you have low libido? Do you have symptoms of depression, anxiety, or irritability? Have you lost your zest for life, even when nothing is wrong? Do you often feel weak or tired even though you have had enough rest? Have you noticed a loss of body hair on your legs, arms, or face? Do you have a loss of muscular strength, muscle mass or tone? Have you gained weight despite eating or exercising the same amount? Do you have a family history of prostate or testicular cancer? Do you sometimes have trouble focusing or remembering things? Do you sometimes feel disoriented or have foggy thinking?

Testosterone is essential to the feeling of well-being for men. It gives them their motivation, joi-de-vivre or spark for life, and makes them feel more confident. And it obviously has important implications for normal sexual function as well. Normal doses do not cause “roid rage” as many people fear. In fact, men with normal levels of T are often calmer, more patient and less irritable than men with low T values. As with any hormone, it is important to get the level “just right” because too little will not work, and too much can cause negative side-effects. T helps prevent muscle loss with age, and decreases body fat. It helps prevent diabetes and metabolic syndrome. T helps prevent anemia, and keeps bones strong – men on T replacement have fewer bone fractures and fewer deaths from cardiovascular causes. TRT decreases inflammation – high CRP, IL-6, and TNF-alpha are reduced. There is very little evidence to support that testosterone supplementation to restore levels to an optimal range can cause health problems. Numerous research articles support the opposite. Study participants and researchers have noted gained muscle, a slowdown in bone loss, increased sexual desire, and better cognitive skills.

Studies have shown that men with low testosterone can become frail, lose muscle mass and suffer bone fractures due to osteoporosis. Some data has suggested that testosterone therapy can lead to increases in muscle mass and strength. Researchers also have shown that men who are testosterone-deficient may be more likely to experience depression and reduced quality-of-life than men who produce adequate amounts of the hormone. Other signs of low testosterone in men may include decreased sex drive, poor erections by the penis; erectile dysfunction (ED), lowered sperm count and reduced fertility, or increased breast size. Men also may have symptoms similar to those seen during menopause in women – hot flashes, increased irritability, inability to concentrate, and depression. T replacement has been shown to help prevent Alzheimers, and protect cerebral blood flow, decrease angina, and decrease TNF alpha (a pro-inflammatory marker).

Low testosterone levels can cause nervousness, irritability, insomnia, depression, antisocial tendencies, crying spells, suicidal tendencies, inability to concentrate, weakness, fatigue, muscle pains, muscle loss, weight loss, constipation, decreased urinary force, urinary frequency and hesitancy, reduced sex drive, erectile dysfunction, infertility, loss of vitality, osteoporosis, prostatic disease, vascular disease, inflammatory and neurological diseased. Conversion of male testosterone to estrogen from chemicals, pesticides and plastics can cause excessive estrogen risk.

Decreased T levels are associated with increased cholesterol and triglycerides leading to increased arterial plaque and coronary vasoconstriction which can cause rising blood pressure and cause heart disease. Low T can increase insulin output, which leads to obesity and diabetes, and increased abdominal fat. Low T can cause increased estrogen levels and increased lipoprotein A and fibrinogen, which can cause blood clots. Decreased T can lead to decreased HGH output and decreased energy and strength, leading to decreased physical activity and obesity, which also raises Estradiol – the vicious cycle of male menopause. All smooth and striated muscles respond to Testosterone, but the most responsive muscle is the heart. Testosterone in optimal levels seems to be good for the heart.

T can convert to DHT. DHT does not convert to estrogen, but can cause more male pattern baldness.

The issue of Prostate Cancer:  There is an unfounded fear in the general medical community that T replacement therapy can cause prostate cancer. Many new studies have shown this not to be true, but old ideas die hard.  No evidence suggests that testosterone supplementation causes prostate cancer. In fact, studies show a higher incidence of prostate cancer in men with a lower baseline level of testosterone. It does appear that there is an association of high estrogen levels in men and prostate cancer. Have you ever heard of a teen-age male (with the highest testosterone levels) having prostate cancer? Studies have shown that men with the highest levels of T had no greater risk of prostate cancer and no greater symptoms of urination problems – i.e. benign prostatic hypertrophy (BPH). However, a pre-treatment screen for prostate cancer is important, with a digital rectal exam by a qualified practitioner, and a PSA (Prostate Specific Antigen) level less than 4 (ideal is less than 2.5). If there is a problem with urine flow, a urology consult is important. The most common cause of an elevated PSA is BPH (Benign Prostatic Hypertrophy), or Prostatitis – inflammation of the prostate gland from either an infectious or inflammatory cause. It is a good idea to take supplements such as Saw Palmetto to help with prostate symptoms. There was no increase in the PSA even with high doses of T. Saturation of the androgen receptor occurs early at 60-90 ng/dl (very low levels of T). One study found that the greater the severity of T deficiency, the greater the risk of prostate cancer and there was an increase in the highest grades of prostate cancer. Some studies have shown that you can find 5-7 microfoci (tiny spots) of prostate cancer even in men in their 20’s and 30’s. If a man lives long enough, he is likely to develop prostate cancer. Many times it is very slow growing, and sometimes it is better left alone. Statistically, only around 7% of prostate cancers will metastasize, so sometimes “watchful waiting” is a good approach. Some studies do suggest that in the presence of pre-existing prostate cancer, testosterone supplementation may accelerate tumor growth. However, in Europe, some men with prostate cancer are treated with testosterone, so this is an unresolved issue. Men taking testosterone supplementation should have twice yearly PSA tests and once yearly manual examination of their prostate gland to monitor this issue.

Side-effects of Testosterone therapy can include: decreased sperm count, decrease in testicle size (1-3%), increased libido, gynecomastia (less than 1%), increase in hemoglobin and hematocrit (approx 5%), acne (1-2%), edema (less than 1%), male pattern balding, elevated blood pressure, occasionally priapism (an erection that lasts too long). Rare side-effects (usually seen if the dose is too high) include: increase in body hair, liver problems, high blood pressure, heart problems or hardening of the arteries, gallstones, kidney disease.

It is important to understand that not all men will benefit from Testosterone supplementation. Since many hormone levels are interconnected, T hormone supplementation can affect other hormone levels.

Testosterone supplementation must be monitored through blood testing. Men who take too much Testosterone may shut down production of DHEA and other sex hormones. This can cause testicular shrinkage, impotence, the development of breasts (gynecomastia) through increased estrogen production, and infertility. Very high levels of testosterone can lead to severe and dangerous health problems. It is very important not to take more than the recommended amount.