Bio-identical hormones have the same chemical structure as hormones that are made by the human body. The term “bioidentical” does not indicate the source of the hormone, but rather refers to the chemical structure. In order for a replacement hormone to fully replicate the function of hormones which were originally naturally produced and present in the human body, the chemical structure must exactly match the original. Bio-identical hormones are able to follow normal metabolic pathways so that essential active metabolites are formed in response to hormone replacement therapy.
There are significant differences between hormones that are natural to humans (bio-identical) and non-bio-identical (including horse) preparations. Side chains can be added to a naturally occurring hormone to create a synthetic drug that can be patented by a manufacturer. A patented drug can be profitable to mass produce, and therefore a drug company can afford to fund research as to the medication’s use and effectiveness. However, bio-identical substances can not be patented, so scientific studies are less numerous on natural hormones,because medical research is usually funded by drug companies. Structural differences that exist between bio-identical human, and non-bio-identical synthetic and animal hormones may be responsible for side effects that are experienced when non-bioidentical hormones are used for replacement therapy.
Bio-identical hormones include estrone (E1), estradiol (E2), estriol (E3), progesterone, testosterone, dehydroepiandrosterone (DHEA), and pregnenolone. Our compounding specialists work together with patients and prescribers to provide customized bioidentical hormone replacement therapy that provides the needed hormones in the most appropriate strength and dosage form to meet each woman’s specific needs. Hormone replacement therapy should be initiated carefully after a woman’s medical and family history has been reviewed. Every woman is unique and will respond to therapy in her own way. Close monitoring and medication adjustments are essential.
Confusing Research on HRT and the WHI Study
The findings of numerous studies on hormone replacement therapy (HRT) conflict and, as a result, have raised serious questions regarding the appropriateness of HRT. Hormone replacement is an approved therapy for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal atrophy. Numerous studies have confirmed that estrogen replacement decreases the risk of colon cancer, estrogen and progesterone decrease fracture risk, and various hormones increase energy levels and enhance libido. Reputable sources offer conflicting reports regarding issues such as memory, Alzheimer’s disease, and stroke.
With the exception of the Post-menopausal Estrogen/Progestin Intervention (PEPI) study, major studies have either failed to distinguish among types and dosages of HRT used in the study, or examined only the use of synthetic HRT preparations (as in the case of the Women’s Health Initiative). The Women’s Health Initiative (WHI) study was designed to identify the potential risks and benefits ts of HRT. The estrogen-progestin portion of the clinical trial was stopped in 2002 after results showed that a synthetic hormone combination containing conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) increased the women’s risks of developing invasive breast cancer, heart disease, stroke, and pulmonary embolism. The data and safety monitoring board concluded that the risks outweighed the evidence of benefit for fractures and colon cancer. Utilizing data from the WHI, researchers later concluded that synthetic CEE plus MPA does not improve mental functioning and may increase the risk of dementia in women over age 65. They suggest these hormones increase the risk of stroke, which is known to increase the risk of dementia. With regard to the risk of dementia, typical HRT users are in their 50s and the WHI study focused on women aged 65 and over, who have a higher risk for dementia. The “estrogen-only” portion of the WHI study was halted in March 2004 after analysis of data suggested that synthetic CEE alone had no impact either way on heart disease (the main focus of the study), but may increase the risk of stroke.
Many patients and medical professionals are unaware of the availability of bio-identical alternatives. In reality, women’s experiences and clinical outcomes of HRT differ vastly depending on the dose, dosage form, and route of administration, and most importantly, whether the hormones are synthetic or bio-identical. As a result of concerns and doubts generated by studies that use synthetic hormones, many women who could substantial benefit from bio-identical hormone replacement may never have the opportunity.
Estrogens actually refers to a group of related hormones, each with a unique profile of activity. Under normal circumstances, a woman’s circulating estrogen levels fluctuate based on her menstrual cycle. For Hormone Replacement Therapy, these hormones are often prescribed in combination to re-establish a normal physiologic balance. The two main estrogens produced in female humans are:
• Estrone -E1- (10-20% of circulating estrogens) is the primary estrogen produced after menopause.
• Estradiol -E2- (10-30% of circulating estrogens) is the most potent and major secretory product of the ovary, and the predominant estrogen produced before menopause.
Progesterone is a term that is incorrectly used interchangeably to describe both natural bio-identical progesterone and synthetic non- bio-identical derivatives. Synthetic progestins (also called progestogens or progestational agents) are analogues of bio-identical progesterone, and have been developed because they are patentable, more potent, and have a longer duration. Medroxyprogesterone acetate, the most commonly used synthetic progestin, was shown in a large study to cause significant lowering of HDL “good” cholesterol, thereby decreasing the cardioprotective benefit of estrogen therapy. Bio-identical progesterone has not been reported to produce any serious side effects when administered in physiologic doses. However, progestins can have significant and serious side effects at typical doses, including migraine headache, weight gain, mood swings, depression, irritability, acne, menstrual irregularities, and fluid retention. These side effects are a frequent cause for discontinuation of HRT. Only about 20% of women who start synthetic HRT remain on it two years later.
• is commonly prescribed for perimenopausal women to counteract “estrogen dominance” which occurs when a woman produces smaller amounts of progesterone than normal relative to estrogen levels.
• alone, or combined with estrogen, may improve Bone Mineral Density.
• minimizes the risk of endometrial cancer in women who are receiving estrogen.
• is preferred by women who had previously taken synthetic progestins.
• may enhance the beneficial effect of estrogen on lipid and cholesterol profiles and exercise-induced myocardial ischemia in post-menopausal women (in contrast to medroxyprogesterone acetate).
The benefits of progesterone are not limited to prevention of endometrial cancer in women who are receiving estrogen replacement. Progesterone therapy is not only needed by women who have an “intact uterus”, but is also valuable for women who have had a hysterectomy. Vasomotor flushing is the most bothersome complaint of menopause, and is the most common reason women seek HRT and remain compliant. For over 40 years, estrogens have been the mainstay of treatment of hot flashes, but transdermal progesterone cream may be effective as well. Women who have had postpartum depression once have about a 68% chance of having it again after another pregnancy, but trials using prophylactic progesterone have shown that it is possible to reduce the recurrence rate to 7%. Other benefits include improved bone density and enhanced glucose utilization.
Androgens are hormones that are important to the integrity of skin, muscle, and bone in both males and females, and have an important role in maintaining libido. Declines in serum testosterone are associated with hysterectomy, menopause, and age-related gender-independent decreases in DHEA and DHEA-sulfate. DHEA (dehydroepiandrosterone) is an androgen precursor from which the body can derive testosterone. After menopause, a woman’s ovaries continue to produce androgens; however, the majority of the androgens produced in the female body, even before menopause, come from peripheral conversion of DHEA. As the body ages, production of DHEA declines so that by the time a woman goes through menopause, the production of DHEA is often inadequate. Additionally, ERT may cause relative ovarian and adrenal androgen deficiency, creating a rationale for concurrent physiologic androgen replacement. Recently, attention has turned to the addition of the androgens to a woman’s HRT regimen in order to alleviate recalcitrant menopausal symptoms and further protect against osteoporosis, loss of immune function, obesity, and diabetes.
Androgens, such as testosterone and DHEA:
•enhance bone building (increase calcium retention).
•provide cardiovascular protection (lower cholesterol).
•improve energy level and mental alertness.
Our compounding pharmacy professionals can prepare:
• Unique dosage forms containing the best dose of medication for each individual.
• Medications in dosage forms that are not commercially available, such as transdermal gels and creams, topical creams and ointments, buccal troches and lollipops, and chewable medications.
• Medications free of problem-causing fillers such as dyes, sugar, lactose, or alcohol.
• Combinations of various compatible medications into a single dosage form for easier administration and improved compliance.
• Medications that are not commercially available.
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