Bioidentical Hormone Therapy for the Perimenopause and Menopause

Perimenopause is the start of a progressive hormone deficiency state that causes physical symptoms, which may be quite obvious, such as hot flashes, night sweats, vaginal dryness, loss of sex drive, as well as psychological symptoms such as mood swings, incapacitating anxiety and depression. Over time, chronic hormonal deficiencies of estrogen and testosterone result in the development of other medical issues that have no outward symptoms, but may become problematic some years after menopause has begun. The deterioration of the bones (osteopenia/osteoporosis) and loss of muscle mass (sarcopenia) and strength, as well as mental changes such as diminished intellectual capacity, memory loss, and even dementia are all connected to chronic hormonal deficiency.

The outward effects of untreated hormone deficiency is dramatic, as seen in women who have undergone a premature menopause, losing their periods in their 20’s or early 30’s. In the past, these unfortunate women were not treated with hormonal replacement therapy and by the time they reach their forties appear to be 10-20 years older than their true age. Without hormonal replacement, by the time they reach their fifties, they look like a woman well into her seventies. Suffering with advanced osteoporosis, their quality of life is poor because they suffer with all the physical and emotional effects of chronic hormonal deficiency. Fortunately, such cases are not often seen today because of the availability of safe and effective bioidentical hormone replacement therapy with estrogen, progesterone and testosterone.

Female hormonal deficiency also contributes to cosmetic aging. Collagen production is reduced and thinning of the papillary fibers occurs, both of which give skin its elasticity and maintains smooth, wrinkle free skin. The lack of estrogen and testosterone also affects a woman’s hair, causing diffuse hair loss and changes in its texture. Just as the effect of low estrogen and testosterone on the skin and hair usually begins early in the perimenopausal period, hormone deficiency progressively affects the bones, muscles, brain and causes the accumulation of belly fat. The effect of low estrogen and testosterone on the brain creates psychological and emotional symptoms such as depression, anxiety, mood swings and loss of libido, which is one of the earliest signs of testosterone and estrogen deficiency. Hormone replacement therapy is usually successful in enhancing energy, strength, motivation and libido, as well as reducing anxiety and depression caused by hormonal deficiency.

Fortunately, hormone replacement therapy with natural Estrogen, Testosterone, and Progesterone, identical to the hormones produced by the ovaries during a woman’s reproductive years, is available and can safely correct some of the hormonal void created by the inevitable failure of a woman’s ovaries.

Symptoms of Low Estrogen

  • Hot flashes
  • Night sweats
  • Moodiness
  • Irritability
  • Trouble concentrating
  • Weight gain
  • Increased belly fat
  • Decreased sex drive
  • Painful sex
  • Dry vagina
  • Low libido
  • Insomnia
  • Bone pain
  • Pathologic fractures
  • Headaches

Symptoms of Low Testosterone

  • Fatigue
  • Low libido
  • Muscle weakness
  • Muscle flabbiness
  • Bone pain
  • Osteoporosis
  • Insomnia
  • Anxiety
  • Brain fog
  • Difficulty orgasming
  • Insomnia
  • Dry or thinning hair
  • Weight gain
  • Depression
  • Low motivation

The Diagnosis and Treatment of Female Hormone Deficiency States: Understanding the Roles of Symptoms and Blood Test Results in its Management

It is important to note that treating female hormone deficiency states, such as perimenopause and menopause, is very much like treating hypothyroidism in that it must be diagnosed and treated clinically by its symptoms and not by blood test results. Diagnosing hormonal deficiencies is much more complex than simply seeing whether or not blood test results fall within the laboratory reference range. A person can have all their hormone levels fall within the laboratory reference range, yet still have the clinical symptoms of hormonal deficiency, and actually be deficient in both estrogen and testosterone. This is due to the fact that estrogen and testosterone, like thyroid hormone, function biologically inside of the cells of the body and are not reflected by the levels of hormones found in the blood. There is no way to directly measure the amount of hormone that gets inside of a cell. However, when there is an inadequate amount of hormone inside the cells, cellular function is compromised and causes a person to experience clinical symptoms of a hormone deficiency. Consequently, the presence of clinical symptoms are a clear indicator that there is a hormonal deficiency that requires treatment. Symptoms occur when there is a shortfall between the amount of hormone the body is capable of producing and the amount of hormone that the body requires to function normally. The shortfall is the amount of hormonal medication required to eliminate a person’s symptoms. When a hormone deficient person is taking an adequate amount of hormonal medication, they no longer are symptomatic.

Blood tests may be helpful in the diagnosis of some cases of hormonal deficiencies, but may also be problematic when physicians become over-reliant on them, ignoring their patient’s symptoms and relying exclusively on blood test results to diagnose and treat hormonal deficiencies. The major problem in diagnosing most endocrinologic conditions is a misunderstanding of the actual meaning of the term Reference Range that is given for each blood test on a laboratory report. Years ago, it was originally called the Normal Range. Normal is a statistical term which is a kind of average. IT HAS NOTHING WHATSOEVER TO DO WITH A PERSON’S HEALTH. IT DOES NOT MEAN THAT WHEN A PERSON’S RESULTS FALL WITHIN THE REFERENCE RANGE THAT THEY DO OR DO NOT HAVE A CERTAIN MEDICAL CONDITION! To eliminate this confusion, in 1987 the terminology on standard laboratory reports was officially changed from the Normal Range to the Reference Range or Reference Interval.

Unfortunately, even after many years most people, as well as many physicians, still have the term “normal” fixed in their minds as meaning medically normal. While this works for many blood tests, such as blood counts, liver enzymes, or blood sugar levels, which measure substances in the blood caused by abnormal physiologic functions, it is not able to detect hormonal abnormalities caused by an inadequate amount of hormones within the body’s cells. A person’s clinical symptoms are the only way to detect abnormal intracellular function leading to symptomatic hormonal insufficiency. When clinical symptoms are ignored, many individuals who are actually living in a state of hormonal deficiency are misdiagnosed because their blood test results fall within the reference range. Unfortunately, when blood test results are misinterpreted or misunderstood, and a person’s symptoms are ignored, they will go without treatment that could have greatly improved their health and quality of life.

Although the “official party line” about menopausal treatment is that a woman should not receive hormone replacement until cessation of her menstrual periods, it is absolutely ludicrous to deny treatment to menstruating women during the perimenopausal period, when the symptoms are usually most intense. If a woman is struggling with the symptoms of female hormone deficiency, she should begin treatment whenever it is needed, even if her periods are still regular. Just because hot flashes, which are the most obvious and annoying symptoms of perimenopause and menopause, will usually stop on their own, the chronic deficiency of estrogen and testosterone remains an ongoing process, causing progressive deterioration of the bones, muscles, heart, skin and brain which can, by the time a person reaches their 70’s or 80’s, will end in irreversible physical and mental damage. It is crucial to remember that just because the hot flushes stop, it does not mean that a woman’s state of hormonal deficiency has been cured.There is a very compelling case for lifelong hormone replacement therapy for both sexes for a healthier and better quality of life.

Dr. Melnick Publishes Article on Thyroid Blood Testing »

Why do Many Symptomatic Women Fear Treatment with Hormone Replacement Therapy?

Twenty years ago a highly publicized study, the Women’s Health Initiative Study (WHI), collected data to determine the safety of hormone replacement therapy. It was stopped prematurely because the authors claimed from preliminary data that there was a much higher than expected incidence of breast cancer in a group of women who were treated with menopausal hormone replacement therapy with estrogen and progesterone medications that were commonly in use prior to the 1990’s, but were no longer used by most physicians by the time that the study was published.

The dramatic termination of the study was quite unusual and the media immediately spread the word that treatment with estrogen causes breast cancer. The association of the words breast cancer and hormonal therapy was the kiss of death for the hormonal treatment of the menopause. There was an instantaneous drop of 60-80% in the number of women taking hormonal treatments for menopausal symptoms. Although the women in the WHI study were treated with hormones that were quite different from natural bioidentical hormones in use today, all types of female hormones were stigmatized. A huge number of women went "cold turkey" off their hormones and suffered through menopause without hormone replacement therapy.

Years later, the WHI authors repudiated the results of their own study. They admitted to serious flaws in their study’s design that led them to draw totally erroneous conclusions about the dangers of hormonal therapy.

Years after all the damage was done, the authors admitted that hormonal therapy was not as dangerous as they had originally stated and that there was no proof that estrogen actually caused breast cancer. Unfortunately the press hardly made any mention of the authors’ revised findings, despite its monumental significance. The finding that estrogen did not really cause breast cancer was more than newsworthy, but the damage was already done. Once the court of public opinion hands down a guilty verdict, it is impossible to declare a mistrial!

The Aging Process and Hormone Replacement Therapy

As early as the late 1880s, physicians had figured out that the loss of ovarian function was the cause of the symptoms of what is now known as menopause. They used extracts of animal ovarian tissues to successfully eliminate hot flashes in menopausal women. In the early 1940s, the first pharmaceutically produced oral estrogen, Premarin, an extract of various forms of horse estrogens from pregnant mare’s urine, came to market. Premarin had been used for 50+ years, successfully eliminating many symptoms of menopause. Although it is still available in pharmacies, it has largely been replaced by non-oral forms of bioidentical estrogens because of a small, but increased, incidence of blood clots in women taking oral estrogens. Estrogens are best administered by skin patches, creams or subcutaneous pellets. Bioidentical estrogens, having the exact molecular structure as the estrogens produced by a woman’s ovaries, are recommended instead of synthetic estrogens or estrogens sourced from animals.

The female hormone progesterone plays a crucial role as a balancing agent when estrogen is given to women. Progesterone must be given to balance the stimulatory effect of estrogens on the lining of the uterus, when present. If not taken, the endometrial lining can thicken and irregular vaginal bleeding can occur, which is both bothersome and anxiety provoking. There is a small possibility that estrogen therapy which is not balanced by progesterone can result in precancerous changes in the inner lining of the uterus that may morph into actual uterine cancer. Progesterone is also very helpful as a sleep aid and as relief from symptoms such as mood swings, anxiety, difficulty concentrating, headaches and depression, which are very much like those found in PMS (Premenstrual Syndrome).

Unfortunately, hormone replacement therapy with testosterone, which is an essential female hormone that is also produced by the ovaries, is frequently omitted from menopausal hormone replacement therapy. Although testosterone's physiologic role in the treatment of menopause is of equal importance to that of estrogen, its benefits are less well known to many physicians, so it is not commonly added to the typically prescribed estrogen and progesterone menopause treatment protocols. There is a great deal of data that supports the use of testosterone therapy for its beneficial effects on both the mind and the body. When used properly, testosterone safely supports good health, reduces the risk of breast cancer, and greatly improves the quality of life for people of both sexes in their “golden years.”

A large part of the aging process is due to a reduction in the amount of thyroid hormones, estrogen and testosterone that our bodies produce as we age. When these hormones are deficient, testosterone and thyroid hormone replacement therapy can boost energy, increase muscular strength and exercise tolerance, and help with weight loss and the conversion of fat to muscle. These hormones also remove “brain fog” and restore mental clarity, improve intellectual function, help with insomnia and increase motivation. Low sex drive and difficulties with sexual performance are also helped by hormonal replacement therapy. There is also evidence that testosterone therapy may prevent the development or progression of age related cognitive impairment.

An inescapable part of the aging process in women is a generalized deterioration of bones called Osteoporosis, which is the direct result of menopausal hormone deficiency of both testosterone and estrogen. Osteoporosis causes the bones to become fragile, causing fractures to occur with little or no trauma. Osteoporosis impacts the lifespan and quality of life of every woman over the age of 50. It is caused by a progressive decrease in hormone production which typically starts in the fourth decade in the female life cycle. It is diagnosed via a simple bone scan, which every woman should have by the time that they are in their mid fifties. The advantage of screening is that a bone scan can detect an early stage of osteoporosis, called osteopenia. The presence of osteopenia is an early warning sign that hormonal treatment should be started to prevent its inevitable progression to osteoporosis. If there is a late diagnosis and osteoporosis has already developed, estrogen and testosterone replacement can reverse the process of bone degeneration by causing bone regrowth that can be as much as 8% per year. When osteopenia or osteoporosis has been diagnosed, it is strongly recommended that in addition to estrogen/testosterone replacement therapy, a consultation be obtained with a physician that is experienced in nonhormonal treatment options that may be complementary to hormonal therapy.

Testosterone Therapy

Testosterone is the forgotten menopausal hormone. If a lady asks her menopausal friends taking hormonal replacement therapy which hormones they are taking, all will answer estrogen and progesterone. It is unlikely that any are being treated with testosterone. The fact that a woman’s ovaries normally produce considerably more testosterone than estrogen prior to the onset of the perimenopause is largely unknown. When the ovaries gradually start to “burn out” as a woman enters the perimenopause, she eventually becomes deficient in both estrogen and testosterone. If a woman is deficient in both hormones, why is only estrogen and not testosterone replaced? The most probable answer is that among both patients and physicians, there is a fear of potential cosmetic side effects that could be produced by testosterone. The incidence of these side effects depends upon the way that testosterone is administered and its dosage.

The route of testosterone delivery is the key to the dual problems of preventing potential side effects from excessive dosage, yet at the same time, ensuring that the dose is adequate for symptomatic relief. Oral testosterone, while it is effective in pill form, is not recommended because of potential liver toxicity. Testosterone injections, commonly used in men, are not recommended for women because they are very likely to cause side effects such as acne, excessive body hair, deepening of the voice and enlargement of the clitoris. Testosterone skin patches are available for men, but are not very effective in relieving the symptoms of testosterone deficiency. Testosterone skin patches are not available for women because they were not proved effective in clinical trials.Testosterone skin or vaginal creams, made in compounding pharmacies, are available for women. Generally, when testosterone cream is applied to the skin, it is not well absorbed and offers little or no symptomatic relief. However, compounded testosterone creams for vaginal use are absorbed better through the vaginal tissue than the skin. When using testosterone cream, it is important to check the blood level of total testosterone to ensure that its absorption is adequate. The testosterone levels should be well above the top of the laboratory reference range to ensure adequate testosterone absorption and symptomatic relief. It is important to note that the blood levels of total testosterone, although not useful for diagnostic purposes, is important to insure in order to be therapeutically effective and must be significantly higher than the top of the reference range. The incidence of side effects depend on the presence of peaks and valleys in hormone levels rather than a constant level of hormone release like the way pellets release testosterone. With intermittent dosage, like injections or even creams, the peaks are very high after administration and drop off steeply prior to the next scheduled dose.

The best vehicle for testosterone replacement therapy in terms of clinical efficacy and low incidence of side effects is via subcutaneous implants of bioidentical testosterone. The implants last for 3-4 months before replacement becomes necessary. Virtually painless to implant, and with a less than 1% rate of minor complications, it is considered to be transformational by many men and women.

The Rebirth of Hormone Pellet Therapy

It's hard to believe that the most effective treatment for hormonal deficiency, subcutaneous testosterone pellet implants had been “hiding in plain sight” for 60 years, before it was rediscovered in the early 2000’s. First used in the 1940’s, tiny testosterone pellets were implanted under the skin of women who had radical hysterectomies for cancer to prevent the acute menopausal symptoms that occur after surgical removal of the ovaries in premenopausal women. Testosterone, by injection or by the implantation of pellets, was also used to treat women who had metastatic breast cancer. Testosterone showed promise in slowing progression of the disease as well as improving the quality of life of the patients with advanced breast cancer. The main reason that pellet therapy did not catch on was that the early work with testosterone pellets was going on at the same time that Premarin, the first oral estrogen for the treatment for menopausal symptoms, came to market.The simplicity of taking a pill such as Premarin, made it the “gold standard” for menopausal therapy and totally captured the world’s market for the next 40-50 years. During those years, because Premarin was effective in relieving menopausal symptoms, there was no apparent need for alternative menopause treatments, so testosterone pellet therapy fell by the wayside.

Hormone Pellets

The hormone pellets are placed under the skin in the upper part of the buttocks with a local anesthetic. The procedure for women takes only 10-15 minutes to perform and is painless once the initial injection of local anesthetic into the skin has been completed. There is a mild degree of local soreness that lasts for 3-4 days. Pellets last for a period of 3-4 months before symptoms start to return and another pellet implantation needs to be performed.

Prior to the initial pellet insertion, blood test results, as well as the patient's demographic information and medical history, are plugged into a computer program. Based on clinical information and laboratory results from many thousands of patients, it gives a suggested starting dose of testosterone and estrogen, if it is to be included in the hormonal treatment. The doses of estrogen and testosterone in the pellets are extremely low when compared with other methods of hormone replacement therapy, but are effective because of their placement close to tiny blood vessels under the skin, which allows direct absorption of hormones at a steady rate, avoiding the peaks and troughs of blood levels that cause side effects. In women, most commonly used doses of testosterone pellets range from 100 mg to 200 mg for a 3 month period. With a 150mg pellet, a woman receives a testosterone dose of approximately 50 mg per month. The threshold for testosterone side effects such as acne and increased body hair, is over 300mg per month, so testosterone pellet therapy is unlikely to cause much in the way of side effects because of excessive dose. That said, there are some women who are genetically predisposed to excessive body hair and acne, who will have an increase in skin breakouts and body hair despite low doses of testosterone. These side effects can be managed by a pill called spironolactone, which blocks the effect of testosterone on hair follicles and sweat glands.

The most commonly used estrogen doses range from 10mg to 15mg for three to four months. Progesterone is taken orally at bedtime at a dose of 200mg. When taken along with testosterone, it is very helpful for women with sleep disorders and helps limit mood swings, hot flashes and night sweats.

Four weeks after the first pellet insertion, blood levels of hormones are measured to ensure proper absorption. If the absorption is not adequate and there is no symptomatic improvement, an additional pellet, called a booster, is implanted at no cost. Although most patients do experience some degree of symptomatic relief starting as early as two weeks after implantation, it is important to note that two or even three pellet cycles may be needed for patients to experience the full benefits of pellet therapy.

Complications are quite rare. In a series of 376,000 patients published in the Journal of Therapeutic Advances in Endocrinology and Metabolism, the complication rate was less than 1%. Complications reported were bleeding, infection and pellet expulsion.

It is important to note that only testosterone pellets, without estrogen, are used to treat perimenopausal women. Any woman who may still get regular or even occasional menstrual periods is still producing some estrogen, although on an irregular basis. It is common for perimenopausal women’s ovaries to develop small cysts that produce high levels of estrogen. Adding estrogen pellets in this situation may cause women to experience unpleasant side effects caused by excess estrogen: sore, tender breasts, weight gain, extreme bloating and water retention, headaches, fatigue, insomnia and mood swings. Fortunately, some of these symptoms can be lessened with diuretics. However, since the pellets last for 3 months and cannot be removed once implanted, it is best to eliminate estrogen pellets for this group of ladies and not add it until a woman has gone without a period for one year.

Hot flashes, vaginal symptoms, sleep issues, fatigue, depression, and low libido can be adequately treated by a combination of testosterone pellets and oral progesterone therapy, without the addition of estrogen. It is important to note that the treatment of menopausal hormonal deficiency and its symptoms can be successfully managed by testosterone therapy only, without prescribing estrogen and progesterone.

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