Bioidentical Hormone Therapy

Abstract

The change in hormonal milieu associated with perimenopause and menopause can lead to a variety of symptoms that can affect a woman's quality of life. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for these symptoms. However, combined HT consisting of conjugated equine estrogen and medroxyprogesterone acetate has been associated with an increased number of health risks when compared with conjugated equine estrogen alone or placebo. As a result, some women are turning to alternative hormonal formulations known as compounded bioidentical HT because they perceive them to be a safer alternative. This article defines compounded bioidentical HT and explores the similarities and differences between it and US Food and Drug Administration-approved HT. We will examine the major claims made by proponents of compounded bioidentical HT and recommend strategies for management of patients who request bioidentical HT from physicians. The change in hormonal milieu associated with perimenopause and menopause can lead to a wide variety of symptoms that may negatively affect a woman's quality of life. The most common symptoms include hot flashes, night sweats, emotional lability, poor concentration, and sleep disturbance; these can range from mild to severe. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for menopausal symptoms. In the United States, a number of US Food and Drug Administration (FDA)-approved hormone preparations are available for treatment of women with menopausal symptoms.2 In 2002, results from the estrogen plus progestin (E+P) arm of the Women's Health Initiative (WHI) revealed an increased risk of breast cancer, cardiovascular disease, stroke, and thromboembolic events in women taking conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) compared with those in the placebo group.3 These findings prompted many women to discontinue HT or to seek a safer alternative to FDA-approved HT for treatment of menopausal symptoms. As a result of the WHI, many women ask their physicians for non-FDA-approved compounded bioidentical HT (CBHT), which is also known as natural HT, believing that it is safer than FDA-approved therapy. 3,4 It is estimated that CBHT is a multibillion-dollar industry, possibly affecting millions of women. 5 WHAT WE LEArnED FroM THE WHIThe findings of the E+P arm (CEE and MPA) of the WHI that were published in 2002 dramatically changed the prescribing practices of physicians in the United States. 6 Before the trial demonstrated adverse cardiovascular disease events and a 26% increased risk of breast cancer in female participants, the number of women for whom E+P was prescribed had been steadily increasing, from 58 million in 1995 to 90 million in 1999.6 From 1999 to 2002, the numbers stabilized; however, within 3 months of publication of the WHI findings, prescriptions for E+P decreased by 63%. Many women stopped HT and some sought out alternative therapies for treatment of symptoms associated with menopause.6 In add...

Risks and Effectiveness of Compounded Bioidentical Hormone Therapy: A Case Series

“…Although these custom hormone combinations often include blends of the same ingredients found in FDA-approved BHT (i.e., plant-derived 17b-estradiol or micronized progesterone), some customcompounded BHT preparations include additional hormone varieties (i.e., estriol, pregnenolone, dehydroepiandrosterone (DHEA), and testosterone) that have not undergone adequate testing and are therefore not included in any FDA-approved products. 5 We will review several cases seen in our midlife women's referral clinics, which demonstrate concerns for the safety and efficacy of BHT. JMP is 53-year-old white female who comes to discuss bothersome vasomotor symptoms that have been occurring for the last 2 years.…”

“…The FDA recommends against using hormone levels to guide the dosing of HT. 5 This customized BHT is often advertised as being a safer, more effective, natural, and an individualized alternative to conventional HT. However, these claims remain unsupported by any large-scale, randomized clinical trials, and the lack of FDA oversight generates additional risks regarding the variable purity, potency, efficacy, and safety of custom-compounded BHT.…”

“…Commonly used preparations of compounded BHT are listed in Table 1. 5 Compounding is defined by the FDA as ''the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner's prescription, to produce a drug tailored to an individual patient's special medical needs.'' 6 Salivary hormone testing is often used to personalize the doses and combinations of hormones included in a custom-compounded BHT regimen; however, salivary hormone levels are known to fluctuate widely and have not been shown to be related to menopausal symptoms.…”

Method Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Female Hormones in Hormone Concentrates Creams

“…During pregnancy, for example, Estriol is the predominate estrogen that remains in a woman's unbound blood circulation, while Estrone becomes the dominate estrogen during menopause. Progesterone is the predominate progestogen that is involved in the menstrual cycle, and it supports pregnancy and the ability of the female to carry a baby to term [3]. All estrogens are synthesized in the body from androgen (male) steroid hormones by the action of aromatase enzymes, with the androgens Dehydroepiandrosterone, Testosterone, and Androstenedione becoming Estriol, Estradiol, and Estrone, respectively, upon metabolism by aromatase [4,5].…”

“…One, or more commonly a combination of several of these hormones can be used to treat female disease states that result from low hormone levels due to hypogonadism or age-induced menopause or surgical menopause. Hormone Replacement Therapy (HRT) supplements low estrogen levels, and therefore, serves an important role to alleviate uncomfortable symptoms like hot flashes or mood swings to more serious conditions like osteoporosis and dementia [3]. Additional Progesterone dosed as HRT reduces symptoms of severe PMS, treats certain types of infertility, and can support pregnancies in those that are high-risk, preventing miscarriage [6,7].…”