Bio-Identical Hormone Replacement Therapy
Current research and compelling information on alternatives to traditional hormone replacement therapy has resulted in an increased public interest in bio- identical hormones.
Restoring Balance
Nova offers an individualized bio-identical hormone replacement program tailored to meet the needs of men and women seeking to restore hormone balance. This customized program has helped countless patients frustrated by traditional therapies and provides an option for those concerned by the highly publicized risks and side effects of synthetic hormones. In addition to hormone balancing, conditions such as fatigue, depression, reduced muscle definition, weight gain and decreased libido can often be improved with a lifestyle program based on sound nutrition, regular exercise and stress management. This approach has become a welcomed alternative to conventional oral hormone replacement therapy for peri- and post-menopausal women, as well as men who suffer from hormone deficiencies.
Nova has offered patients a complete array of bio-identical hormone therapy services since 2002. Unlike many commercially available hormones, bio-identical therapies are chemically identical to the hormones men and women have throughout their youthful life. Made from yams and purchased with a prescription at a compounding pharmacy, bio-identical hormones prescribed in a cream formulation, eliminate first pass metabolism (processing in the liver). It is possible that many of the increased risks associated with the Women’s Health Initiative Study may be secondary to this aspect of metabolism. Similar to the HERS (Heart and Estrogen/Progestin Replacement Study) research trial, both studies found that the use of oral conjugated estrogens (Premarin and Provera) increased (not statistically significant) the risk of breast cancer (26-27%). The Women’s Health Initiative Study also identified unacceptable increases in cardiovascular events and strokes. For this reason the study was halted. More recently, the Premarin only treatment group was halted from further study for similar increases in cardiovascular risks and strokes, but a significant decrease in breast cancer incidence. These results are very confusing and need further explanation.
Benefits from hormone replacement therapy include; reduction of colon cancer (37% WHI and 19% HERS) and 24% reduction of osteoporotic fracture risk (WHI). In the meantime, women must make choices about hormone replacement. Due to the current state of research findings, it is not clear if using bio-identical hormones increases the risk of breast cancer or heart disease. Women must decide for themselves their comfort level with the potential risks afforded by both modalities and the potential risks of not taking hormone replacement.
Our Goals
Our goals include restoring your hormonal levels to that of youthful years and improving your energy level, libido, muscle to fat ratios and eliminating other hormone imbalance symptoms. Patients’ hormone levels are re-tested at regular intervals. Patients treated with bio-identical hormone replacement therapy report fewer mood swings, loss of hot flushes, improved mental clarity and energy levels. Men with low testosterone levels report a generalized improvement in well being, muscle mass, energy and libido when their levels are restored to the youthful range.
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The History of Hormone Replacement Therapy
In 1942, the first drug containing estrogen was marketed and sold as Premarin (pregnant mare’s urine). It was not until 1975, that the first study linking Premarin use and a 4.5 times increased incidence of endometrial carcinoma was published. In 1983, a study revealed that this risk was negated by adding progestin to the regimen. The first study linking a doubling of breast cancer and Premarin was published in NEJM in 1976. More bad news loomed on the horizon for Premarin in the 1980’s with the publication of the Framingham Heart Study showing a 50% increased risk of cardiac morbidity and a more than two fold risk for cardiovascular disease.
This news was countered by the Nurses Health Study, finding lower rates of heart disease in 121,964 post menopausal women than those not taking hormone therapy. By 1989, NEJM reported a 4.4 times increase in relative risk for women taking estrogen-progestin and development of breast cancer. The risk appeared further increased by the addition of progestin. NIH launched the first double blind randomized controlled study on Premarin in 1991. One arm of the study looked at the effects of Premarin and Provera on women with intact uteruses and the other arm looked at the effects of only Premarin on women that did not have a uterus.Both studies were terminated early due to their increased associated risks of heart disease (additional 7 in 10,000 women) and stroke (additional 8 in 10,000 women). Due to study design issues, the fact that symptomatic women were excluded and the relative older age of patients (average 62.3 years), a lot of doubt has been shed on their conclusions.
The Premarin-Provera study revealed that patients had an increased relative risk (1.26 times) of breast cancer (additional 8 in 10,000 women) and the Premarin only group revealed a decreased relative risk (.55 times).These findings suggest that the previously recognized relationship to progestin and breast cancer may be more of a problem than estrogen alone.The reduced risks of colon cancer and osteoporosis associated with hormone use are well established in multiple studies. The Premarin only arm showed a decrease in coronary heart disease in the younger age group women (50-59 times), the hazard ratio (HR) being .59. The media has been relatively silent on these findings.
Years of observational studies finding a beneficial effect while using HRT now appears supported, if used in women before the onset of Coronary Artery Disease (CAD), thus in early, not late menopause.Researchers are now concluding that once CAD has been established, HRT has no beneficial effect and may be harmful.The arm of the WHI study that looked at dementia, was comprised on women of average age of 71 years, an age after vascular damage has already started.As recently published in Family Practice News, Feb 1, 2004; 69, the crux of observational data confirms that HRT during a critical period (early menopause) is protective against dementia.
Additional data is now being published in support of the use of HRT in women in early menopause (typically age 50-55). JAMA, 2004; 291:3005-07 recently made these claims and indicated that the neuroprotective effects may protect against illness that may develop twenty years later. In 1995, the Nurses Health Study reported a 32% increase of breast cancer with the use of estrogen and a 41% increase with progestin. In 1998, the first large multi-centered, randomized and controlled study, the Heart and Estrogen/Progestin Replacement Study (HERS) found an increased risk of coronary heart disease incidents of 52% during the first year of therapy in women with known coronary heart disease. Studies on the patented 17-Beta estradiol, chemically more similar to women’s natural hormones than Premarin, have not shown the deleterious effects of HRT found with the equine preparations such as Premarin.
Premarin has a different chemical composition as the hormones found in this preparation are native to the horse, not human. In addition to hormone balancing conditions such as fatigue, depression, reduced muscle definition, weight gain and decreased libido can often be improved with a lifestyle program based on sound nutrition, regular exercise and stress management. This approach has become a welcomed alternative to commercial HRT by Nova patients. Nova has offered patients a complete array of bio-identical hormone therapy services to men and women since 2002. Unlike many commercially available hormones, BIO HRT is chemically identical to hormones found in men and women in their youthful life. Made from yams and purchased in a compounding pharmacy with a prescription, transdermal application of BIO HRT eliminates first pass metabolism (processing in the liver), a process that may be responsible for many of the unwanted side effects of commercially available hormones. While science has not provided all of the answers, men and women must make informed choices about hormone replacement and know that there are uncertainties with the recommendations for or against HRT. Nova is not making any statements about the linking between current research on Premarin or 17- Beta Estradiol and the inferences of risk and benefit to patients taking BIO HRT.
Estrogen is a group of similar hormones with several different functions. The three estrogens produced by a woman’s body are estrone (10%), estradiol (10%) and estrio (80%). Women produce these hormones in very specific quantities. To keep the body in proper balance, these hormones must be replaced in the same amounts. Estradiol and estrone are more potent hormones, while estriol is a weaker estrogen that may actually have protective qualities. There is research evidence that estriol may protect against breast cancer, prevent vaginal dryness, urinary incontinence and infection and reduce the risk of blood clots. Estradiol (E2) is metabolized into estrone (E1) and estriol (E3) by enzymes (known as 2 hydroxylase, 4 hydroxylase and 16 a hydroxylase) present in many differerent tissues including the liver. The 16 a hydroxylated compounds are further metabolized to estriol ( the end product of estradiol and estrone). The 2 hydroxyestrones are protective or good estrogens and their levels are decreased by obesity, tagamet and corn oil diet. Their levels are increased by high protein, low fat diets, exercise and a supplement known as indole 3 carbinol. They provide a strong anti-oxidant function. The 4 hydroxyestrone is thought of as a bad estrogen and may induce the production of free radicals. 16 a hydroxylestrone is the immediate precursor of estriol in a non pregnant female. Bradlow et al and others have shown that a high ratio of 2:16 hydroxyestrone is beneficial in preventing breast cancer. These ratios may be manipulated by ingesting diets high in cruciferous vegetables, soy, low animal fat, and taking isoflavones and Phytoestrogens.
Natural progesterone is chemically different than synthetic progestin. Natural progesterone does not produce the deleterious effects on cholesterol found with the use of synthetic preparations. Natural progesterone promotes new bone formation, may help protect against breast cancer, increases metabolism and decreases breast cyst and uterine fibroid formation.
Testosterone is a hormone most women think is only for men, however, both sexes must have a normal level of this hormone to feel and function well. Testosterone levels decline for men and women throughout their life. Testosterone has several functions including maintaining sex drive, adequate energy level, increase bone and muscle strength, decrease weight gain and improve self esteem. BIO HRT offers relief of hot flashes, irritability and mood swings, night sweats and chills, insomnia, low sex drive and vaginal dryness. Long term benefits of BIO HRT include possibly decreased risk of heart disease, decreased risk of osteoporosis, decreased risk of dementia and risk of colon cancer. Our goals include restoring the hormonal levels to the youthful years, improving quality of life, eliminating unwanted symptoms and providing our patients with the most up to date interpretation of the literature enabling good decision making.
It appears that the research currently does not support the use of HRT for the purpose of prevention of stroke or dementia if initiated in women over the age of 65, but probably has beneficial effects in the younger population. Women more at risk for colon cancer or osteoporosis, may elect to start HRT at any age if the risk benefit ratio appears best for them. The negative findings of HRT research have been based on the use of oral synthetic preparations and not BIO HRT. It is very conceivable that the different metabolism involved with BIO HRT does not stimulate the same coagulation complications as set in action with metabolizing the synthetic hormone preparations. BIO HRT is available in various preparations including creams, pills, sublingual troches, injections and suppositories. We retest hormone levels at regular levels. Expanded options are available to assist you in finding the best approach to obtaining optimal health.