Hormone replacement therapy (HRT) or in Britain, Hormone therapy (HT), is a system of medical treatment for surgically menopausal, perimenopausal and to a lesser extent postmenopausal women. It is based on the idea that the treatment may prevent discomfort caused by diminished circulating estrogen and progesterone hormones. It involves the use of one or more of a group of medications designed to artificially boost hormone levels. The main types of hormones involved are estrogens, progesterone or progestins, and sometimes testosterone. It often referred to as "treatment" rather than therapy.
Overview
HRT is available in various forms. It generally provides low dosages of one or more estrogens, and often also provides either progesterone or a chemical analogue, called a progestin. Testosterone may also be included. In women who have had a hysterectomy, an estrogen compound is usually given without any progesterone, a therapy referred to as "unopposed estrogen therapy". HRT may be delivered to the body via patches, tablets, creams, troches, IUDs, vaginal rings, gels or, more rarely, by injection. Dosage is often varied cyclically, with estrogens taken daily and progesterone or progestins taken for about two weeks every month or two; a method called "sequentially combined HRT" or scHRT. An alternate method, a constant dosage with both types of hormones taken daily, is called "continuous combined HRT" or ccHRT, and is a more recent innovation. Sometimes an androgen, generally testosterone, is added to treat reduced sexual desire/(libido). It may also treat reduced energy and help reduce osteoporosis after menopause.
HRT is often given as a short-term relief (often one or two years, usually less than five) from menopausal symptoms (hot flashes, irregular menstruation, fat redistribution etc.). Younger women with premature ovarian failure or surgical menopause may use hormone replacement therapy for many years, until the age that natural menopause would be expected to occur.
Attitudes towards HRT changed in 2002 following the announcement by the Women's Health Initiative of the National Institutes of Health that those receiving the treatment (Prempro) in the main part of their study had a larger incidence of breast cancer, heart attacks and strokes. The WHI findings were reconfirmed in a larger national study done in the UK, known as the the Million Women Study. As a result of these findings, the number of women taking hormone treatment dropped by almost half. The Journal of the American Medical Association and elsewhere based on these findings warn that women with normal rather than surgical menopause should take prescribed HRT treatment at the lowest feasible dose, for the shortest possible time. For health problems associated with menopause such as osteoporosis (a small percentage of postmenopausal women are at risk of severe bone loss), other life-style changes and/or medications are now recommended.
Types of hormone therapy
Proprietary mixtures of conjugated equine estrogens (CEE) have been a common prescribed form of HRT, as well as progestins that, while not progesterone, approximate its effects. Studies have shown that certain risks are associated with these combinations of progestins and equine estrogens. Because these have been used most commonly and for the longest time, there are many more studies of these forms of hormones than of some of the newer forms with newer delivery systems, and therefore the most is known about these kinds. Whether or not such risks exist with other forms of estrogens and progestins, and other delivery systems, remain to be seen.
Bioidentical forms of human estrogen and progesterone have not been studied very much. This distinction is important, because the adverse biological effects of xenoestrogens and progestins revealed by studies of Premarin and Prempro do not necessarily generalize to supplementation with human forms of estrogen and progesterone. For example, a pilot study reported in JAMA by Smith, Heckbert, et al. found clinical evidence that oral conjugated equine estrogens caused clotting, but the other estrogen compound tested in the same study, bioidentical esterified estrogens, does not. Conjugated equine estrogens were found to be associated with increased venous thrombotic risk. In sharp contrast, the study found that users of esterified estrogen had no increase in venous thrombotic risk.
Additionally, the route of administration may be as important as the type of estrogen administered. For example, in a large study published in The Lancet Scarabin et al. compared effects of oral vs. transdermal skin patch estrogen (mainly estradiol-17 beta, the "bioidentical" human estrogen) and found that the oral route was associated with a 3-fold increase in risk of venous clotting disease (thrombophlebitis, pulmonary embolus), whereas the skin patch produced no excess risk. This difference was likely due to the fact that transdermal estrogens are absorbed directly into the bloodstream, while oral estrogens are processed and changed by the liver before release into the blood stream.
Studies finding adverse health effects of equine estrogens and progestins have often been reported, inaccurately, as revealing effects of "estrogen" and "progesterone". It is important to keep this habitual inaccurate generalization in mind in reviewing press reports. On the other hand, creams, gels, etc, containing "bioidentical" hormones custom-prepared by compounding pharmacies are not subject to FDA monitoring or regulation, so that doses delivered and hormone blood levels produced are unpredictable and may be highly variable, and there are fewer large-scale studies of these items.
It has become increasingly clear that oral progestin and equine estrogen pills can increase a number of risks, including the risks of exacerbation of existing liver or gallbladder problems and of dangerous blood clots. Long-term use of equine estrogens probably also increases the risk of breast cancer.. In women with a uterus, therapy with equine estrogen, unopposed by progesterone, is generally acknowledged to increase the risk of uterine cancers in women with intact uterine linings. This proprietary combination can also affect blood triglyceride levels and increase the risk of adverse cardiovascular events. Although HRT with progestins and equine estrogens was once widely thought to promote cardiovascular health in women, on February 4 , 2004 , the American Heart Association released guidelines stating that it should no longer be considered as an agent to increase heart health or to decrease the chances of cardiovascular disease.
In 2006, results from the large, ongoing, observational Harvard Nurses' study showed that those taking a pill containing a combination of estrogen with methyltestosterone (a synthetic testosterone analogue) had higher risk of breast cancer than those not taking the methyltestosterone. Unfortunately, few or no studies have tested the safety or benefits of human bioidentical testosterone, or of low-dose non-pill administration of testosterone that avoids the first pass through the liver.
Due to the risks and potential problems of progestins and equine estrogens, a number of alternative therapies have been developed, including lifestyle changes, botanical non-hormone drug therapy (phytoestrogens), and bioidentical hormone replacement therapy. To reduce the risk of osteoporosis without hormones, dietary changes that increase calcium uptake, exercise, and drugs such as biphosphates, selective estrogen receptor modulators, or calcitonin have been tried.
HRT has been proven to be more effective than exercise in reversing the effects of aging on muscle. A future aim is to target therapy to molecular mechanisms that work specifically in selected tissues. This can reduce the extent and severity of side effects.
Conjugated equine estrogens
Conjugated equine estrogens contain estrogen molecules conjugated to hydrophilic side groups (e.g. sulfate). They are produced from the urine of pregnant mares, hence the product name Premarin, the most-prescribed form. In the sister product, Prempro, Premarin is combined with a synthetic progestin, medroxyprogesterone acetate. However Premarin, and especially Prempro, are associated with serious health risks.
In January 2003, the FDA required Wyeth to affix a "black box" warning to Prempro, stating
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI ... "
Bioidentical hormone replacement therapy
Main article: Bioidentical hormone replacement therapyRecently, interest in "bioidentical" hormone replacement therapy (BHRT) has risen. This term is used to refer to HRT formulated to contain the three main naturally occurring human estrogens estradiol, estrone, and estriol, as well as to refer to bioidentical human progesterone and sometimes testosterone. As recently as 2004, before the release of the Women's Health Initiative (WHI) studies referred to below, the relative benefits of bioide
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