Female Hormone Replacement Therapy – Controversies

Few topics in medicine have created more confusion for millions of women than the controversies surrounding hormone replacement therapy (HRT). For many years, physicians recommended HRT to menopausal women, based upon studies demonstrating significant health benefits and protection against everything from heart disease and osteoporosis, to colon cancer and Alzheimer’s disease. Then, in a sudden about-face, along came a study that lead to a mass discontinuation of HRT. Findings from the Women’s Health Initiative (WHI) suggested that the risks associated with HRT use outweighed any benefits. The new evidence showed an increased risk for heart disease, breast cancer and strokes. How could the WHI conclusions about the safety of HRT be so conflicting with previous studies and result in a virtual flip-flop in the medical advice given to women? As the dust has settled and after more in-depth analysis, it appears there is some truth in all the studies. The secret is in understanding what each one is telling us.

Physician guidelines regarding hormone replacement therapy were previously driven by findings from a number of research studies such as the Nurses Health Study, a 20-year prospective cohort study of 120,000 women under age 55. It found that HRT use was associated with significant reductions in cardiac events as well as cardiovascular and total mortality. The more recent Women’s Health Initiative, a 5-year randomized trial with 16,000 women, found an increased incidence in cardiac events associated with HRT, although with no increase in either cardiovascular or total mortality. Why are the conclusions at variance? The truth is that the outcomes from both studies were largely correct. They were both right but differed principally in the timing when hormone replacement therapy was initiated. Women in the Nurses Health Study generally started HRT within 2 years of menopause, while those in the WHI did not start HRT until 10 years after menopause.

Estrogen is thought to have protective properties against cardiovascular disease in premenopausal women, and that the risk for atherosclerosis begins to rise as estrogen levels decline after menopause. Substantial evidence supports the use of hormone replacement therapy for the primary prevention of atherosclerosis in women, but only if started during the early postmenopausal period and before the onset of atherosclerosis. Once atherosclerosis has already developed, however, HRT has no effect at reversing the process and may actually promote plaque destabilization and thrombosis. This largely explains the different outcomes from the Women’s Health Initiative compared to earlier studies.

What about an increase in cancer risk with hormone replacement therapy? The WHI consisted of two clinical arms. The first arm was the Hormone Replacement Therapy (HRT) trial, using estradiol (an oral form of estrogen) and progestin (an oral form of synthetic progestin, known as medroxyprogesterone acetate). The Estrogen Replacement Therapy (ERT) trial made up the second arm, using only estrogen. The HRT trial found 8 more cases of breast cancer but 6 fewer cases of colon cancer for every 10,000 women, compared to the control group. On the other hand, women receiving only estrogen in the ERT trial demonstrated a small, though not statistically significant, reduction in breast cancer cases, in addition to fewer cases of colon cancer. Several observational studies also found HRT to be associated with reduced mortality for cancer of the colon. The conclusion from this and previous studies is that the progestin used in the HRT trial of the WHI increases a woman’s risk for breast cancer. Progestin appears to be the culprit regarding breast cancer risk, not estrogen. It is noteworthy that the WHI found no increase in breast cancer deaths or total cancer deaths in either trial.

 It is worth noting the following facts about the women in the WHI trials: It was a 5-year trial of 16,000 women, with a mean age of 63.3 years, 70% of the women had a body mass index (BMI) greater than 25 (classifying them as either overweight or obese), nearly 50% smoked, and some of the women already had pre-existing heart disease. In other words, a significant percentage of the women in the trial were already at risk for heart disease. Moreover, the women given estrogen and progestin were dosed using a continuous dose, orally, of each hormone. As previously mentioned, one of the most noteworthy facts is that hormone replacement therapy (HRT) was initiated several years post-menopause in many of the women, the mean age being 63.3 years when HRT was introduced for the first time.

Two more recent investigative studies have been published which provide additional support to the relative safety of using HRT. The National Health and Nutrition Examination Survey (NHANES) and the Iowa Women’s Health Study (IWHS) reported no increase in risk of breast cancer. The NHANES was a large prospective study based on a nationally representative sample of the U.S. population followed for 22 years. The IWHS grouped breast cancer into three groups: ductal carcinoma in situ, cancer with favorable histologic finding and invasive ductal lobular carcinoma. No increase risk for breast cancer was associated with HRT treatment. Furthermore, women who did develop breast cancer on HRT were highly associated with favorable prognostic histological findings.

Yet another recent study, from the University of Southern California (USC), found virtually no increased risk with continuous combined HRT. Long term HRT (10-15 years) conferred no greater risk for breast cancer than non-use, and carcinomas that did develop had a better prognosis than the other types. Finally, ERT compared to non- use gave protection against the development of cardiovascular disease. For each case of breast cancer, more than six deaths from heart disease were prevented with ERT use.

Of perhaps greater concern for women than breast cancer is osteoporosis. One in six Caucasian women in the U.S. will fracture her hip, and this is greater than the risk of developing breast cancer or gynecological cancer. In white women 50 years and older, the lifetime risk of osteoporotic fractures approaches 40 percent. To make matters worse, as many as 33% patients die within one year of hip fracture. Osteoporosis is responsible for almost 1 million vertebral and hip fractures annually. The Women’s Health Initiative demonstrated that hormone replacement therapy is associated with a 35% reduction of hip fractures.

Hormone replacement therapy has beneficial effects in conditions other than cardiovascular disease, cancer, and osteoporosis. Some studies have shown that HRT is associated with a reduction of cases of new-onset diabetes mellitus by as much as 35%, and a 60% reduction in recurrent urinary tract infections. Diabetic women who use hormone replacement therapy are more likely to have their blood sugar under control and have lower cholesterol levels than women who never used hormone therapy. Glycosylated hemoglobin, HbA1c, an indicator of poor blood sugar control, tends to be lower amount diabetic women using HRT. HRT users tend to have higher levels of ApoA, a protein component of HDL that allows it to remove excess cholesterol from the blood stream. HRT appears to lower levels of Fibrinogen, a protein associated with increased risk of coronary heart disease. Moreover, it may reduce the risk for Alzheimer’s disease. In cell cultures, gender-specific bioidentical estrogen or testosterone supplementation appears to slow the accumulation of tau protein, neurofibrillary tangle, and amyloid in human neurons, reducing the potential for Alzheimer’s disease.

Findings from a meta-analysis of 30 randomized controlled trials involving hormone replacement therapy were published in a 2004 issue of the Journal of General Internal Medicine. The analysis included several notable trials, such as the Women’s Health Initiative. The authors concluded that while the risks of initiating HRT in older women or in the presence of coronary heart disease may outweigh the benefits, HRT use was not associated with any change in mortality. Furthermore, the authors concluded that the benefits of HRT outweigh the risks if treatment is begun in younger women who do not have coronary heart disease or breast cancer. The report found that initiating HRT in younger postmenopausal women actually resulted in a 39% reduction in mortality.

Current guidelines for hormone replacement therapy have confined its use to short-term symptom treatment only, using the lowest dose possible. A better understanding of the seemingly conflicting evidence suggests that hormone replacement therapy can still provide significant health protection for many women.

Estrogen

Estrogen is a hormone made primarily in the ovaries. Some testosterone is also converted to estrogen through an enzyme process known as aromatization. “Estrogens” are the primary female sex hormones. The three major estrogens are estradiol, estriol and estrone. Of the three, estradiol is the most physiologically and biologically active. This synthetic formulation is most commonly prescribed in its conjugated form, such as Premarin. Synthetic estradiol is frequently not well absorbed and may result in some unwanted side effects. Estrone, known to relieve some of the symptoms of menopause, is sometimes selectively used in bio-identical hormone replacement therapy. Some of the metabolites of estrone, however, have genotoxic effects, and are associated with some forms of cancer. The third major estrogen, estriol, is considered a weak estrogen. And while it is beneficial, such large doses are required to treat menopausal symptoms, compared to estradiol that frequently the side effects are too much for women to handle. Huge amounts of estriol are produced during pregnancy. However, it should be noted that estriol is the only form of the three that has actually been shown to have an anti-cancer effect. It is commonly combined with estradiol for hormone replacement therapy.

Estrogen is not simply a sex hormone, but a total body hormone. Some of the hormone receptor sites that need estrogen are found in the bladder, bones, arteries vagina, heart, liver and the brain. Without adequate levels of estrogen these organs cannot function properly.

Estrogen has been shown to protect against:

  • Colon cancer
  • Osteoporosis (with estradiol blood levels > 50-75)
  • Heart disease
  • Stroke
  • Increased cholesterol
  • Incidence of Alzheimer’s
  •  Memory loss
  •  Symptoms of menopause

Between the age of about 35 and 50 years, estrogen levels decline slowly, by approximately 25 percent. Female hormone levels of estrogen drop drastically at menopause. After menopause heart disease in women skyrockets, surpassing the rate found in the male population. In fact, it is the leading cause of death in older women with over a half-million deaths per year in the US, more than twice as many as all cancer deaths combined. Young women, who make large amounts of estrogen, rarely have osteoporosis, macular degeneration, or osteoarthritis, and they rarely die of cancer, heart disease Type II diabetes, or Alzheimer’s disease. Young women, too, overall, are not incontinent, too cold, too hot, or plagued by unrelenting insomnia.

The Women’s Health Initiative (WHI) study demonstrated an increased risk overall with the synthetic hormones. While the study found a statistically significant reduction in colon cancer and osteoporosis, a statistically significant increase in the incidence of breast cancer, heart attacks and strokes was noted.

Recall that more recent analysis of the WHI data suggests that HRT actually reduces the risk for heart disease when administered among women in their early 50s, yet may have harmful effects when therapy is initiated among women a decade older. The reason is that estrogen has both beneficial and harmful effects on plaques of atherosclerosis – the cause of heart attacks.

To understand this issue it helps to know how heart attacks happen. Plaques of atherosclerosis form in the heart’s arteries. Each plaque develops a cap made of thin fibers. Cholesterol lies beneath this cap. Heart attacks and many strokes occur when the cap ruptures, spilling cholesterol into the middle of the artery. After that, a blood clot forms and the artery constricts to slow the flow of blood to a part of the heart muscle, starving it of the oxygen and sugar it needs.

Estrogen, particularly the bioidentical form, slows the development of atherosclerotic plaques, by lowering LDL (“bad”) cholesterol, raising HDL (“good”) cholesterol levels, and reducing other markers of inflammation. Estrogen has an antioxidant effect on free radicals, which helps prevent harmful oxidation of LDL cholesterol. Taking a vitamin E supplement helps the antioxidant effect of estrogen. Estrogen also produces vasodilatory factors such as nitric oxide and prostacyclin and inhibits synthesis of the vasoconstrictor, endothelin-1. The net result is a decrease in vascular resistance and lower blood pressure.

For this reason it may be desirable that women begin estrogen replacement therapy early in menopause, before estrogen levels have been low long enough to allow atherosclerotic changes to begin. In other words, HRT may decrease the risk of heart disease in relatively younger women by slowing the development of plaques. However, estrogen may make existing plaques more likely to rupture by increasing inflammation in them. This is why it may be harmful to wait and initiate estrogen replacement therapy in much older women and in women with pre-existing atherosclerosis. The WHI outcomes suggest that this is true. The risk of developing heart disease was lower for women taking HRT at younger ages, but it was higher for women starting hormones many years after menopause, particularly with known atherosclerosis. The bottom line is that estrogen and progesterone is not for every woman.

As previously discussed, estrogen replacement therapy does not appear to increase the risk of breast cancer, but rather the synthetic progestin (medroxyprogesterone acetate) does. Additional factors may contribute to an increased incidence of breast cancer, such as toxic substances found in many food and water that accumulate in fat cells, including fat cells of breast tissue. Soy estrogens block the effect of these toxic substances and therefore further protect a woman from getting breast cancer.

Characteristics of Estrogen Deficiency

  • Mental fogginess
  • Forgetfulness
  • Depression
  • Minor anxiety
  • Mood changes
  • Difficulty falling asleep; insomnia
  • Hot flashes – vasomotor hot flashes do not correlate with estrogen levels
  • Night sweats
  • Temperature swings
  • Day-long fatigue
  • Decreased sense of sexuality
  • Decreased libido
  • Harder to reach climax
  • Pain with sexual activity
  • Dry eyes, skin and vagina
  •  Lessened self-image
  • Sagging breasts and loss of fullness
  • Bladder symptoms
  • Breakthrough bleeding
  • Dry skin or hair
  • Hair loss

Characteristics of Estrogen Dominance (ratio of estrogen to progesterone is too high, even if the absolute level of estrogen is low)

  • Premenstrual mood swings, depression
  • Impatient, snappy behavior
  • Breast swelling, fibrocystic breasts
  • Increase of breast size
  • Craving for sweets
  • Heavy or irregular menses
  • Pelvic cramps
  • Sleep disturbances: insomnia or heavy fatigue
  • Uterine fibroid
  • Weight gain, fat deposition at the hips and thighs
  • Acne, skin break-out
  • Water retention, edema

Estrogen in Men

Many men who can boast normal levels of testosterone nonetheless exhibit characteristic symptoms of the male menopause. They find their energy diminishing and their sexual life faltering. If this situation is due to a hormonal imbalance, it may not be related to testosterone. Frequently it is in the level of estrogen, the female hormone, where the trouble lays.

Men react with surprise when they learn the male body contains its own natural supply of estrogen. They are equally unprepared for the news that estrogen is a normal aspect of their hormonal makeup. The male body actually manufactures the female hormone from testosterone. An enzyme in the body, aromatase, converts a small portion of testosterone into estrogen, a process necessary for the healthy functioning of estrogen- sensitive tissues in a man’s body.

It is likely that estrogen is beneficial to the male brain. Estrogen is definitely important in influencing certain natural sexual functions through its effects on brain chemistry. The very areas of the brain involved with sexual function require estrogen for its special purposes in those specific locations. When it comes to estrogen levels, however, the effective range in the male body is very narrow. Too little estrogen will neuter a man just as effectively as too little testosterone. Low levels of estrogen may be harmful to the brain and bone density. Too much estrogen can displace testosterone at various cellular receptor sites, switching off important cellular activities.

As we grow older, aromatase levels tend to increase, resulting in greater estrogen production. In addition, methods for eliminating estrogen, once it has been created, decline. Consequently, the middle-aged man becomes estrogen dominant. By the time a man reaches his fifties, the estrogen level in his body may actually exceed that found in a menopausal woman on estrogen replacement therapy. The changing ratio of testosterone to estrogen is a major factor underlying a common form of male menopause known as metabolic andropause. The testosterone: estrogen ratio is more important than the absolute level of estrogen.

Estrogen Dominance in Men

Estrogen dominance develops slowly in men. The most common causes of midlife estrogen increases in males include:

  • Age-related increases in aromatase activity
  • Obesity
  • Alteration in liver function
  • Zinc deficiency
  • Overuse of alcohol
  • Drug-induced estrogen imbalance
  • Ingestion of estrogen-enhancing food or environmental substances
  • Excess testosterone by injection
  • Chronic  stress;  cortisol  competes  with  progesterone  at  the  progesterone receptors, losing the counterbalancing effect of progesterone.

High estrogen levels are associated with increased risk of heart attacks in males – the exact opposite of its effect in females, in whom it has cardioprotective effects, dilating the coronaries, decreasing clotting factors and revving up the body’s natural clot-busting system. Increasing levels of estrogen in men may adversely affect the prostate gland. Some studies have found that men with higher estrogen levels are more likely to develop benign prostatic hypertrophy. In many men, high estrogen levels cause an actual reduction in testosterone production, and reduce the effective availability of testosterone. A relative excess of estrogen to testosterone diminishes male sexuality. By overlooking the effects of estrogen in males, physicians have found themselves at a loss to explain the failure of testosterone replacement therapy in men who seem ideally suited to it. Observations of these failures have lead many physicians to conclude that testosterone is not significantly related to male midlife changes. In such instances, the failure may be in neglecting the other side of the equation – estrogen.

The problem of estrogen dominance may not simply be a result of natural metabolic changes in hormone conversion and in hormone excretion. The environment and many foods we consume expose us to numerous synthetic estrogens. Many herbicides and pesticides produce an estrogenic effect. Several of the chemicals given to livestock and poultry are estrogenic.

Common causes of elevated estrogen levels in men should be addressed first whenever the levels climb. Fat cells convert testosterone to estrogen. Moreover, obesity is associated with lower testosterone levels. If you are overweight, begin a calorie-restricted, Mediterranean-type diet, with minimal or no grains. As the pounds drop off, so will many of the symptoms of male menopause. Increasing consumption of cruciferous vegetables, such as broccoli and cauliflower, will stimulate removal of excess estrogen. The phytoestrogens in a diet rich in soy compete with estrogen receptor sites, block its actions, and stimulate the liver to process and excrete excess estrogen. Avoid grapefruit, as it tends to inhibit the liver’s breakdown of estrogen. Alcohol significantly inhibits clearance of estrogen from the blood and reduces zinc levels. Consider reducing consumption of alcohol or give up drinking altogether.

Some nutritional supplements have been found to help restore a proper balance of estrogen to testosterone. Many men can reduce estrogen levels by supplementing with zinc, which inhibits the conversion of testosterone to estrogen. Vitamin C and chrysin may further improve the testosterone to estrogen ratio slightly.

A number of prescription and over-the-counter medications have the potential to increase estrogen levels. They include some drugs within the following categories: anti- inflammatory drugs, cholesterol lowering drugs, anti-depressants, heart and blood pressure medicine, antibiotics and antifungal agents.

Symptomatic estrogen dominance that is unresponsive to the measures outlined may require prescription intervention that is more intensive, such as an aromatase inhibitor, e.g., Arimidex.

Progesterone

Progesterone, primarily a female hormone but also found in males in small amounts, is made in the ovaries, the adrenal glands, and in the placenta during pregnancy. It is one of the major regulatory hormones. Without it rising cyclically, the woman becomes, on the cellular level, out of control. Like estrogen, progesterone levels decline with age. Female progesterone levels drop drastically at menopause.

Benefits of Progesterone

Progesterone helps estrogen levels remain within a therapeutic range and therefore, can protect against endometrial cancer of the uterus. Progesterone also:

  •  Stimulates  osteoblasts,  protecting  against  osteoporosis  by  promoting  bone growth.     The  effect  of  progesterone  on  bone  health  may  be  of  greater significance than estrogen’s effect of delaying the loss of old bone.
  • Downregulates estrogen receptor sites.
  • Protects against breast cancer.
  • Enhances a protective gene system (known as P53), which slows down another gene system (BCL2) that promotes cancer.
  • Down-regulates a gene that acts similar to cancer-promoting BCL2.
  • Prevents cells from proliferating excessively in breast and uterine tissue.
  • Enhances natural killer cells and interleukin-2.
  • Increases apoptosis.  This process deters cells from mutating into harmful forms due to oxidative and chemical reactions in the body. Estradiol slows down apoptosis.
  •  Reduces the ability of breast cancer cells to metastasize.
  • Natural progesterone protects against breast cancer by decreasing ductal cell proliferation. It can decrease ductal stimulation by 400%.
  • Increases the production of the anti-cancer estrogen known as estriol.
  • Useful for patients with estrogen-receptor positive breast cancer.
  • Decreases fluid retention; it is a natural diuretic.
  • Normalizes blood clotting.
  • Helps maintain normal blood sugar levels.
  • Assists  in  lowering  LDL  cholesterol  levels.     Micronized  progesterone  and estrogen lead to the greatest improvement in raising HDL and lowering LDL.
  • Improves libido.
  • Has a sedative effect on the central nervous system.
  • Protects brain cells.
  • Increases the sense of well-being.
  • Stabilizes mood.
  • Anti-estrogenic.
  • Suppresses nuclear estradiol receptors.
  • Induces estradiol dehydrogenase 17 beta-HSD 2,4.
  • Suppresses DNA synthesis.
  • Increases the sulfotransferase activity.
  •  Suppresses conversion of testosterone to DHT.
  • Is a precursor for cortisol.
  • Blocks  binding  of   Aldosterone  to   renal  receptors,  can   lower  circulating testosterone.
  • Supports the thymus.
  • Increases ventilatory chemoresponsiveness.
  • Reduces NFk-beta.
  •  Natural progesterone, but not Provera, enhances the beneficial effect of estrogen on exercise-induced myocardial ischemia in postmenopausal women.

Causes of Low Progesterone

  • Aging
  • Impaired production
  • Low LH
  • Increased prolactin production
  • Stress
  • Antidepressants
  • Excessive arginine consumption
  • Sugar
  • Saturated fat
  • Deficiency of vitamins A, B6, C, Zinc
  • Decreased thyroid hormone

Natural Progesterone

  • Is a precursor to estrogen and testosterone
  • Helps balance estrogen
  • Increases the breakdown of fat
  • Lowers blood pressure
  • Reduces arterial spasms
  • Is anti-proliferative and may protect against some forms of cancer, such as breast cancer
  • Protects  against  endometrial  hyperplasia  as  well  as  medroxyprogesterone acetate (e.g. Provera)
  • Reduces breast density
  • Maintains endometrium of the uterus and protects against endometrial cancer
  • Is a natural diuretic
  • Natural calming effects and is a natural anti-depressant
  • Improves mood
  • Restores libido
  • Inhibits cholesterol buildup
  • Increases HDL
  • Lowers LDL
  • Reduces foam cell formation
  •  Prevents  osteoporosis by  stimulating osteoblasts to  form  new  bone  and  by interfering with glucocorticoids, which cause bone loss
  •  Leaves the body quickly
  • Improves sleep
  • Increases scalp hair
  • Helps balance fluids in the cells
  • Increases the beneficial effects of estrogen on BV
  • Increases metabolic rate

Synthetic Progestins

  • Is a teratogen
  • Increase the risk of birth defects, such as heart and limb defects, if taken during the first four months of pregnancy
  • May increase blood pressure
  • May  lead  to  sudden  or  partial  loss  of  vision,  thrombophlebitis,  pulmonary embolism and cerebral thrombosis
  •  Increase the risk for coronary artery spasms
  • Worse cardiac outcomes with estrogen than progesterone and estrogen
  • May cause fluid retention
  • May cause or contribute to depression
  • May cause acne, alopecia and hirsutism
  • Decreases T3 thyroid uptake and thyroid regulation
  • When  taken  with  estrogens,  symptoms  may  be  worse:  Increases  estrogen dominance
  • Stimulates estrogen receptor sites
  • Have negative effects on lipids (negates estrogen’s lipid lowering properties)
  • Lowers HDL
  • Raises LDL
  •  Increases foam cell formation
  •  Increases endothelial dysfunction
  • Increases breast density

Provera is an FDA-approved synthetic progestin. Progestins are not the same as natural progesterone. Synthetic progestins may produce unwanted side effects such as fluid retention, weight gain, depression and breast tenderness. Progestins tend to cancel the protective effect of estradiol, and promote constriction of the coronary arteries to a significant degree. Natural progesterone, on the other hand, protects the endometrium, preserves the beneficial effects of estrogen on the cardiovascular system and has no negative effects on the blood vessels that supply your heart. Provera has many known potential dangers such as possible birth defects, damage to nerve cells, blood clots, acne, rashes, and breast cancer. Synthetic progestins also tend to make you nervous and can adversely affect your ability to sleep.

Progestins are unnatural drugs that have more side effects than natural hormones. Hormone supplementation with the natural, bioidentical form of the hormone will always have fewer side effects than the patentable analogs. Natural micronized progesterone is made from plant sources; more specifically the wild yam. The molecule is altered to make it bio-identical to human progesterone. Replacement therapy is dosed based upon a woman’s serum progesterone level and her symptoms.

Signs and Symptoms of Low Progesterone

  • Acne
  • Amenorrhea – no periods
  •  Oligomenorrhea – the periods come infrequently
  •  Heavy and frequent period
  • Spotting a few days before the period
  • Anxiety
  • Arthritis
  • Breakthrough bleeding
  • Breast tenderness
  • Cramps
  • Decreased libido
  • Depression
  • Endometriosis, fibroids, adenomyosis
  • Fibrocystic breasts
  • Food cravings
  • Harder to reach climax
  • Headaches
  • Hot flashes
  • Insomnia; sleep disturbances
  •  Mood swings
  • PMS
  • Water retention; bloating
  • Weight gain

Prolonged use of Progesterone without adequate Estrogen

  •  Increases weight
  •  Increases total cholesterol
  • Decreases HDL
  • Increases LDL
  • Increases triglycerides
  • Causes depression
  • Causes fatigue
  • Decreases libido
  • Increases insulin resistance

Non-Estrogen Treatment Options for Menopause Symptoms

Suffering from hot flashes and/or night sweats but do not want to take estrogen?

  • Nutrition

To decrease estrogen

  • Fiber – reduces Estradiol
  • Vegetarian diet

– increases fecal excretion of estrogens

– Reduces  blood  levels  of  estrogens  (up  to  40%)  and testosterone

To increase estrogen

–  Meat, fish, poultry

–   High protein and high fat (saturated)

–    Alcohol

– Soy

The results of the research on soy are inconclusive and contradictory.

Some studies have found that soy has a positive effect on hot flashes, whereas others suggest that there isn’t any beneficial effect. Christiane Northup, MD, in her book The Wisdom of Menopause, cites research that indicates that women who ate 60 grams of soy protein per day in the form of a powdered drink mix had a 45% reduction in hot flashes after 12 weeks. The following servings contain about 35-50 mg of soy isoflavones: one cup soy milk, 1/2 cup tofu, 1/2 Tempeh, 1/2 cup green soybeans (edamame), and three handfuls of roasted soy nuts.

-Sip cool drinks

-Avoid

– Carbohydrates, especially high glycemic

– Coffee

– Spicy foods

–  Exercise

Research shows that exercise alone can alleviate hot flashes. In one study, aerobic exercise reduced the severity of hot flashes in 55% of postmenopausal women. For many women choosing not to take HRT, regular weight-bearing exercise and strength training can also help maintain strong bones. Miriam Nelson, PhD, author of Strong Women Stay Young, has done extensive research at Tufts University on the benefits of weight training. Nelson compared two groups of healthy postmenopausal women who were sedentary at the start of the program. One group lifted weights for forty minutes twice a week; the other group remained sedentary. The sedentary control group lost about two percent of their bone density during the year, while the strength-training women gained one percent in bone density. Another study of menopausal women found a 3.5% increase in lumbar spine bone mineral density among women who exercised, compared to a 2.7% decrease in the group of women who didn’t exercise. It is important to avoid excessive exercise, however.

– Lifestyle

o Wear layered cotton clothing

o Avoid stress

o Use ice packs

o Relaxation and deep, abdominal breathing (6-8 breaths per minute) have been  shown  to  reduce hot flashes  by  about  40%  when  practiced as minimally as twice per day

o Eliminate hot baths or showers before bedtime.

– Nutritional Supplementation

o Vitamin E (Natural, mixed tocopherols)

Some women experience a reduction in hot flashes when taking Vitamin E.  However, a placebo-controlled, randomized study evaluated vitamin E supplements (800 IU/day for four weeks) for 120 breast cancer survivors with hot flashes and found that vitamin E only marginally decreased hot flashes.

o Folic acid

o Boron

o Pregnenolone

o Vitamin b6

o B vitamin complex

o Chromium

-Hormones

o Natural progesterone cream

A study published in the journal Obstetrics and Gynecology in 1999 found that natural progesterone cream significantly reduced hot flashes compared to the placebo group. In The Wisdom of Menopause, Northrup says that a 2% progesterone skin cream works in about 85% of peri- menopausal women. As little as 1/4 tsp once per day can ease hot flashes. Make sure that you read the labels of natural progesterone cream products careful as there is great variability of progesterone content.

Some creams contain less than 5 mg progesterone per ounce, whereas others contain more than 400 mg progesterone per ounce. This can be obtained over the counter or by prescription.

– Herbs

An isoflavone or plant estrogen derived from red clover, Promensil, was found to significantly reduce the number and intensity of hot flashes in a study conducted in 1998-99. However, an article by Adriane Fugh-Berman, MD (The (National Health) Network News, July/August 2002) states those trials of red clover were not effective over placebo for hot flash reduction.

Probably the most common herbal remedy for hot flashes is black cohosh. However, the results of trails have been mixed.  Side effects are rare but may include gastric discomfort, nausea, and vomiting. It can, however, lower blood pressure. The general recommendation is to use black cohosh for up to six months continuously. One study using mice suggested that using black cohosh, with undiagnosed breast cancer, could increase the risk for making the cancer more likely to spread.

Dong quai acts like an estrogen and can ease hot flashes for some women. However, Lila Nachtigall, MD, in her book Estrogen states that it is not recommended because it contains psoralen, a known carcinogen.

– Acupuncture and Yoga

The benefits of acupuncture and yoga for menopause symptoms haven’t been carefully studied. Many women, however, say they help. One Swedish study found that women who had acupuncture experienced relief from hot flashes. The benefits lasted several months.  Also, women are increasingly turning to yoga to alleviate menopause symptoms.

Bioidentical Estrogen and Progesterone Replenishment

When dealing with female sex hormones, the balance amongst them often is more important than the actual levels. This is true of the ratio of estrogen to progesterone, as well as estrogen to testosterone. In females, a higher ratio of testosterone to estrogen is indicative of an increased risk of heart disease (the opposite is true in males). In females, as the progesterone to estrogen ratio decreases, it creates estrogen dominance and subsequently an increased risk of breast cancer. Estrogen and progesterone act in tandem to control cell growth for normal function.

Estrogens do many things, including increasing cell proliferation, improving neural connections in the brain, and controlling insulin levels. As total estrogen levels decrease, insulin resistance and insulin levels begin to rise. Progesterone decreases the number of receptor sites for both hormones, decreases insulin resistance and promotes new bone growth (estrogen only slows bone loss). Studies show that estrogen alone causes tissue growth in the uterus that can lead to cancer; however, when replaced in conjunction with natural progesterone, the risk is reduced or eliminated.

Bio-identical estrogens have the same molecular structure as the estrogens found in the human female. These natural plant estrogens are altered so that they have the same bio-identical structure as the estrogens found in human females. Unlike many FDA- approved estrogen medications, natural bio-identical soy-derived estrogens are safe, effective and may have benefits that include:

•   Cancer prevention

•   Protection against osteoporosis by inhibiting osteoclasts, thus slowing bone loss. Estrogen also enhances bone mineral density by renal activation of vitamin D and intestinal absorption of calcium

•   Inhibiting atherosclerosis

•   Inhibiting the free radical damage caused by LDL cholesterol

•   Kidney function protection

•   Gallbladder protection (decreases chance of gallstones)

Combining the benefits of bio-identical estrogen and progesterone replacement provide many of the benefits without the risks. Together they can improve or prevent osteoporosis, improve mood and mental status, improve sexual function or libido. Estrogen and Progesterone can be administered by several different methods:

1.  Progesterone alone (cycle or continuous)

2.  Continuous estrogen plus continuous progesterone

3.  Continuous estrogen plus cyclic progesterone

4.  Cyclic estrogen plus cyclic progesterone

Risks Associated with Estrogen Replacement

Risks associated with estrogen replacement may include

•   Increased body fat

•   Increased fluid retention

•   Depression and headaches

•   Impaired glucose tolerance

•   Increased risk of uterine cancer

•   Gallbladder disease

•   Aggravation of migraines, due to fluid retention

Nutritional Support

While the evidence suggests that estrogen does not cause breast cancer, when prescribing estrogen, a concurrent program of optimum nutrition and nutritional supplementation is advised to minimize breast cancer risks. Cruciferous vegetables and soy foods should be a routing part of everyone’s diet, along with regular exercise –all of which reduce the risk of breast cancer (and prostate cancer in men). Among other protective nutrients such as anti-oxidants, cruciferous vegetables contain a molecule called Indole-3-Carbinol (IC3). IC3 alters the ratio of estrogen metabolites from those known to increase breast cancer risk to benign metabolites. It is difficult to consume enough cruciferous vegetables to achieve optimal protective benefit from Indole-3- Carbinol, so supplementing daily with IC3, or one of its metabolites, DIM, is a wise idea.

Estrogen Replacement Therapy (ERT)

There are no absolute contraindications for progesterone replacement, however estrogen replacement is not recommended for patients with the following conditions:

•   History of breast/uterine cancer

•   History of phlebitis and blood clots

•   History of gall bladder diseases

•   Presence of uterine fibroma

•   Presence of liver disease

Side Effects of ERT

Side effects associated with natural bioidentical estrogen replacement therapy may include

•   Fluid retention

•   Increased body fat

•   Increased risk of uterine cancer if not given in conjunction with natural bio- identical progesterone

Side effects associated with FDA-approved synthetic estrogen and progestin drugs may include

•   Heart attacks

•   Blood clot formation

•   Weight gain

•   Gallstones

•   Headaches

•   Fibroid tumors

•   Irritability

•   Fluid retention.

Signs of Excess Estrogen

•     Full,  painful breasts or  breast  growth  (not  applicable to  women with  breast implants)

•   Fibrocystic breasts

•   Swelling and edema (e.g., difficulty removing rings)

•   Weight gain

•   Irritable and uptight, but mind is clear

•   Headaches

•   Heavy or irregular periods

If these symptoms occur, decrease the dosage of your estrogen slightly and notify the doctor

Signs of Insufficient Estrogen

•   Difficulty falling asleep, restless nights

•   Awaken drenched in perspiration

•   Minimum hot flashes

•   Mind is foggy in the morning

•   Feeling down, not in good control of mood

•   Confused

•   Don’t care how you look

If these symptoms occur, increase the dosage of your estrogen slightly and notify the doctor

Progesterone Replacement

For women who don’t want to take estrogen and just want progesterone

•     Progesterone   provides   balance   against   estrogen   and   every   woman   in menopause has some degree of unopposed estrogen.  Unopposed estrogen can increase the risk of breast and uterine cancer.

•   Be aware that estrogen maintains the cellular receptor sites for progesterone.

Progesterone alone could block some of this estrogen function.   That could actually inhibit some of the ability of progesterone to perform its job Prometrium (capsules) and Crinone (vaginal cream) are two natural products made by pharmaceutical companies. Progesterone is also available through a compounding pharmacy. Sublingual triturates absorb very well. When taking progesterone in a capsule, the liver deactivates most of it. The deactivated progesterone creates a pool of metabolites with a slight sedative-like effect. Vaginal gels are excellent for concentrating progesterone in the uterus and protecting the endometrium.

Progesterone levels are best maintained when it is administered twice daily. When taken as a once daily dose, it is recommended that it be taken at bedtime. For maximum absorption, capsules should be taken during a meal containing some form of fat. Topically applied progesterone usually requires 2-4 weeks to build up sufficient levels in the body to cause noticeable effects.

Stages of Menopause and Conditions Treated with HRT

  •  Pre- and peri-menopause
  • Menopause
  • Post-menopause
  • Sleep and anxiety
  • Damaged ovaries by chemotherapy
  • Urogenital atrophy
  • Stress incontinence
  •  Vaginal atrophy
  • Recurrent urinary tract infections
  • Premenstrual syndrome
  • Menstrual migraines
  • Libido enhancement
  • Arousal disorder

Signs of Excess Progesterone

Signs of excess usually occur very soon after taking progesterone. In mild cases, symptoms do not last more than a few hours, but can last up to eight hours.

  • Mild
  • Nipple tenderness
  • Drowsiness
  • Slight dizziness
  • Sense of physical instability
  • Severe
  • Feeling of being drunk or spinning
  • Heaviness of the extremities
  • Paradoxical (uncommon)
  • Feel antsy, anxious, can’t sleep, retain water
  • Hot flashes or depression
  • Appetite increases and weight gain

If any of these symptoms do occur just back off the dosage of progesterone and notify the doctor.

In menopause, a woman’s body barely makes any progesterone. However, it is still producing some estrogen. Therefore, a situation of estrogen dominance usually exists. It is not highly unusual to have some bleeding initially when beginning progesterone. This results from previous endometrial hyperstimulation from unopposed estrogen. Some women experience unpredictable cycles of heavy, slight, or no bleeding. When this occurs it may be indicating that her estrogen level is still fluctuating. However, most breakthrough bleeding that occurs is usually worse during the first few months of progesterone use and relates more to changes occurring in the endometrium than to fluctuating endogenous hormones.

Any bleeding that develops with the use of progesterone will usually cease within 3 months. You have a few options to address this, although regular periods are certainly not harmful. If the bleeding continues beyond 10 days, contact your doctor.

Menopause is defined as the cessation of the menstrual cycle for at least 12 months. Following the cessation of ovulation, progesterone administration and/or having a period will not induce ovulation. In other words, bleeding does not mean that a woman will become pregnant. Progesterone inhibits the release of FSH, the pituitary hormone that stimulates ovulation.

Monitoring

•     Pelvic ultrasound annually or whenever there is an episode of vaginal bleeding: The doctor will uterine endometrial thickness, with optimal being 5 mm or less

•   Laboratory

  •  Your doctor will monitor your blood work at standard times to assure your obtain optimal and safe levels of your hormones.  Generally, the optimal time for having the blood drawn is approximately 4-5 hours after your morning dose of hormones.

Some patients will find it difficult to precisely measure the prescribed dose of cream- based formulation, depending on how the pharmacist packages it. For example, plungers and syringes are often used to dispense from tubes. Here is a tip to help you ensure that you are using the correct amount of cream-based hormones. Write on the container the date it is opened. When the container is empty you can determine how many days it lasted. If it matches what was expected by the dose instructions, it validates to you were using the correct dose. If a large discrepancy is noted, you should notify your doctor and make adjustments in the how you dispense the cream from the container.

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