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Tuesday Jul 6th 2004
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It is estimated that one in four women suffer severe symptoms during menopause that seriously impair their life. However, recent reports estimate more than 200,000 Australian women may have abandoned chemical HRT in the last two years, following an American study in 2002 that found that chemical HRT increased the risk of breast cancer and heart disease.
About Bioidentical Hormones Bioidentical hormones are derived from plants and have the same chemical structure as the body's natural hormones. They are used as a therapeutic treatment for men and women requiring hormone replacement. Bioidentical hormones differ from other therapeutic hormonal preparations which may have a similar function to the body's hormones, but do not have identical structures. Hormones with different structure are likely to have different levels of activity in the body than the natural hormones and require different metabolism. Pig insulin, for example, was used in the past to treat humans with diabetes due to the lack of a human source of the hormone. While pig insulin had the same function as the human hormone, it had a different chemical structure. In fact, the term 'bioidentical hormones' is most often used in reference to the female and male sex hormones, estrogens, progesterone and testosterone. The terms 'natural' and 'bioidentical' have different meanings. 'Natural' means derived from a natural source rather than from chemical synthesis in the laboratory. Plant estrogen-like compounds, from which bioidentical hormones are derived, are natural to plants, but must be converted to the human form by reactions carried out in the laboratory.
About BHRT BHRT is used for the same purpose as conventional hormone replacement therapy (HRT) to relieve the symptoms of menopause, andropause and other hormone deificiency states. The general term HRT covers all possible combinations of the family of sex hormones, all the different doses used and all of the different means of delivery, such as oral and transdermal via patches or gels. BHRT is HRT that uses combinations of the three bioidentical hormones, estrone, estradiol and estriol and, where appropriate, progesterone and testosterone. Estrone can be converted to estradiol and vice versa. Estrone is also converted to estriol, the most abundant but least active of the three estrogens.
BHRT versus conventional HRT Women respond differently to the hormone formulations used for conventional HRT which may fail to deal with their symptoms (usually those associated with menopause) or make them feel unwell. BHRT offers an alternative to women who do not tolerate conventional HRT well or who make an informed decision to use biodentical hormones instead of hormones with a different chemical structure. The use of bioidentical hormones is the major difference between the two, but other differences include the types and concentrations of estrogens, the method of delivery and the fact that BHRT is not available from a commercial manufacturer. Instead, a prescription for BHRT is provided by the doctor and made up by a compounding chemist on a custom-made basis. The tailor-made formulations used in BHRT are designed to suit the individual’s biology and also their medical history. Bioidentical hormones are convenient in that a custom-made formulation can contain estrogens, progesterone and testosterone in a single lozenge.
Safety of BHRT versus conventional HRT Two large trials of conventional HRT – one estrogen only (E) and the other estrogen plus progestin (E+P) – were terminated earlier due to health risks with long term therapy. The E trial (0.625 mg/day of Premarin™) of 11,000 women without a uterus was stopped at year 7 of 8 because estrogen alone increased risk of stroke, decreased risk of hip fracture, had no effect on heart disease and appeared not to affect the risk of breast cancer. The E+P study (0.625 mg Premarin™ plus 2.5 mg of medroxyprogesterone acetate) was stopped after 6˝ years, because the data showed an increased risk of breast cancer and the risk of breast cancer, coronary heart disease, stroke and blood clots outweighed the benefits on hip fracture and colorectal cancer. The long-term safety of the use of BHRT beyond five years is unknown, however a number of smaller studies of BHRT have reported positive results and, importantly, no adverse outcomes. BHRT falls into a resource-poor area of pharmaceutical therapy because bioidentical hormones are not regarded as 'novel' and are therefore not patentable. The pharmaceutical industry is therefore not prepared to fund the large, long-term clinical trials that can provide the strongest evidence on the safety and efficacy of BHRT. Spokespeople for mainstream medicine point out that long-term results are not available for BHRT, whereas those practitioners who prescribe BHRT have evidence directly from patients that BHRT is a very satisfactory option.
Mara Greco's Story On reaching menopause, Mara Greco consulted with her general practitioner about a treatment to relieve symptoms such as hot flushes. She was prescribed Livial, which acts by blocking estrogen effects on the breast but causes estrogen-like effects to preserve bone. 'My body didn't like it at all. I persevered for almost 12 months, but my body blew up like a balloon and each month I would suffer from incredible itchiness of the skin. I almost scratched myself to death,' Mara said when describing her experience. To counter the itchiness, she was prescribed additional medication, but she was unhappy and realised that the treatment was not for her. Soon after starting the HRT, she spent the Christmas holidays with her family in southern Queensland. 'Every morning we walked from Broadbeach to Surfers Paradise and both my daughter and my husband lost weight, but not me. I continued to gain weight.' She had read about bioidentical hormone replacement therapy (BHRT) in a book by Dr Sandra Cabot called Menopause: Hormone replacement therapy and its alternative which includes information about synthetic and natural estrogens and decided to make enquiries about how where and how she could begin a program of BHRT. Mara was referred to Dr Anne Small and has not looked back. Almost two years later she describes the current state of her wellbeing as follows: 'I do actually feel absolutely wonderful. I don't blow up. I am living for the future and find that I have an extraordinary courage in life that I have not experienced before.' For about four weeks before commencing BHRT, she ceased her other medications and immediately began to feel better. She had tests done on samples of saliva to determine her baseline hormone levels and to enable Dr Small to prescribe a cream for BHRT. For Mara, the first formulation was 'perfect'. She continues to have saliva or blood tests at intervals of six months to check her hormone levels. 'I have friends who take conventional HRT 'off the shelf', but my body didn't like it at all. It was a disaster. I think it's important that women have a choice, after all, it's their body.”
FREQUENTLY ASKED QUESTIONS What are Bioidentical Hormones? Bioidentical hormones have the same chemical structures as hormones produced in the human body. These hormones are prepared in the laboratory from phytoestrogens, particularly those found in soy beans and yams. Phytoestrogens are naturally occurring molecules with estrogen-like properties found in plants.
What are the differences between Bioidentical Hormone Replacement Therapy (BHRT) and Conventional Hormone Replacement Therapy (HRT)? Bioidentical Hormone Replacement Therapy comprises hormones which have the same chemical structure as those produced in our body. Conventional Hormone Replacement Therapy comprises hormones which have a different chemical structure to those produced in our body. BHRT allows for different concentrations of the three major hormone components (estrogen, progesterone, and testosterone) to be used thus allowing individualized prescription. The mode of delivery of BHRT may be different to the mode of delivery of HRT – again, this allows for individualized prescription dosage based on the person’s symptoms. BHRT is prescribed by a Medical Practitioner and prepared by a compounding pharmacist.
BHRT is taken by dissolving a lozenge/troche in the mouth or by applying a cream to skin with underlying fat. Why is this? When a hormone is swallowed and digested, it passes into the bloodstream where it is metabolized in the liver. This process decreases the amount of active hormone in the bloodstream that is available to the body. In dissolving a troche between gum and cheek, or applying a cream which is absorbed through the skin, the concentration of bioidentical hormone in the bloodstream is therefore higher, effectively allowing more hormone to be available for use in the body. Bioidentical hormones are fat-soluble, therefore transport across the skin to fatty tissue aids absorption by the body.
Why do women choose BHRT? Many women find that conventional HRT fails to adequately deal with their symptoms, or makes them feel unwell. These women seek the opportunity for both the individualized dosing available with BHRT as well as the opportunity to tailor formulations to suit their individual biology and their personal and/or family medical history. Increasingly, women have read or heard about successful outcomes with BHRT. Bioidentical hormones have the convenience of providing replacement therapy for any combination of any hormone deficiency in a single preparation – either a troche or cream.
How safe is long-term use of conventional HRT? Two large trials that formed part of the Women’s Health Initiative (WHI) study – one estrogen only (E) and the other estrogen plus progestin (E+P), were terminated earlier than planned. In February 2004, the E trial (0.625mg/day of conjugated equine estrogen – Premarin TM) of 11,000 women who had undergone hysterectomy was stopped at year 7 of 8 because it was deemed that the risks did not outweigh the benefits. Estrogen alone increased the risk of stroke, decreased risk of hip fracture, and had no effect on heart and appeared not to affect the risk of breast cancer. The E+P study (0.625mg Premarin TM plus 2.5mg of medroxyprogesterone acetate) was stopped in July 2002 after 6.5 years because the data showed an increased risk o breast cancer and because the risk of breast cancer, coronary heart disease, stroke and blood clots outweighed the benefits of reduced hip fracture and colorectal cancer. For both the E and the E+P study, there were 8 more strokes per 10,000 women for those on hormone treatment compared with those on placebo.
How safe is long-term use of BHRT? This is not yet known. The safety and efficacy data for BHRT cannot be confirmed beyond five years. One reason is that BHRT has not yet been available “long-term”. Also, bioidentical hormones are not regarded as ‘novel’, so they cannot be patented. As a result they are not regarded as a good investment by pharmaceutical companies and the resources involved in undertaking large-scale, long-term trials are not available. A number of smaller trials have reported no incidence of adverse outcomes and there appears to be no cases in which patients have initiated legal proceedings due to problems caused by BHRT. It is well known that all sex hormones are regarded as potent chemicals and should only be used to manage symptoms of menopause or other causes of hormone deficiency.
How do people obtain bioidentical hormones? BHRT is prescribed by the person’s doctor and prepared by a compounding pharmacist.
Are bioidentical hormones on the Pharmaceutical Benefits Scheme (PBS)? No, however they are covered by private health insurance.
How do patients know they are receiving the correct level of hormones in BHRT? The patient’s doctor will order tests to determine baseline levels of hormones. These tests may comprise serial saliva levels of specific hormones or a blood test. Soon after commencing BHRT, samples will again be collected for testing. If the desired levels are reached the dosage will continue, or, the dosage may be adjusted and the process of monitoring repeated until the correct levels are achieved.
Why are bioidentical hormones not widely promoted? Because there is no advertising budget for bioidentical hormones as they are not commercially produced. In addition many medical practitioners are unaware of bioidentical hormones and their benefits. |


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