Bioidentical hormone

OBJECTIVE: To evaluate whether the increased risk of breast cancer is dependent on the formulation of menopausal hormone therapy (HT) used. METHODS: We performed a population-based case-control study of women aged 50 years or older using data from the U.K. Clinical Practice Research Datalink. Women with incident cases of breast cancer were age-matched (1:10) with a control group of women with comparable follow-up time with no history of breast cancer. Exposures were classified as ever or never for the following menopausal HT formulations: bioidentical estrogens, animal-derived estrogens, micronized progesterone, and synthetic progestin...

Following the release of the Women's Health Initiative data, women began to use compounded bioidentical hormone therapy (cBHT) in the misguided belief of greater safety and efficacy than traditional hormone therapy. New guidelines recommend government-approved hormone therapy for symptomatic healthy menopausal women younger than 60 years or within 10 years of menopause at the time of initiation. For women requesting bioidentical hormones, those similar to the hormones present before menopause, there are many government-approved hormone therapies with extensive pharmacokinetic, safety, and efficacy data provided with package inserts delineating efficacy, safety, and potential risks...

IMPORTANCE: More information is needed about the efficacy and safety of compounded bioidentical hormone therapy (cBHT) in the published literature. A thorough synthesis of existing data is not currently available. OBJECTIVE: To provide a systematic review and meta-analysis of the existing evidence related to the safety and efficacy of commonly prescribed cBHT preparations in perimenopausal and postmenopausal women. EVIDENCE REVIEW: PubMed, ClinicalTrials...

OBJECTIVE: To describe the widespread use of compounded bioidentical hormone therapies (cBHT). To define the term clinical utility and present why there is insufficient evidence to support the overall clinical utility of cBHT products. To recommend actions that pharmacists and regulators can take to promote safer cBHT use. SUMMARY: Nationwide, millions of men and women use cBHT products. Use of these products appears to be increasing year-to-year, according to the limited data reported by the 503 A and 503 B pharmacies that formulate and dispense these products...

The spectacular success of compounded bioidentical hormone therapy is a product of the unanticipated negative-to-neutral findings of the Women's Health Initiative hormone trial and the peculiarities of their regulatory status. By not having to provide scientific evidence of safety and efficacy, a requirement for all Food and Drug Administration (FDA)-approved hormone therapy products, the industry's relatively unfettered marketing now accounts for about one third of menopausal hormone therapy prescriptions...

Endocrine-disrupting chemicals (EDCs) are exogenous compounds that are capable of blocking or mimicking the action of bioidentical hormones. Obesogenic EDCs, commonly called obesogens, play an important role in adipogenesis. This study was carried out to determine the effects of select obesogens and their alternatives on adipogenesis in 3T3-L1 cells under dexamethasone (DEX)-free conditions. Preadipocytes were treated with a cocktail of 3-isobutyl-1-methylxanthine (IBMX) and insulin to which an obesogen (viz...

No abstract text is available yet for this article.

BACKGROUND: Testosterone (T) deficiency (TD) in men and women and estrogen (E) deficiency (ED) in women increasingly affects the overall health and quality of life of patients. T implants have seen increased utilization over the past decade. We evaluated continuation rates and adverse events that occurred during T therapy by reviewing practitioner reported data on compressed human-identical T implants for the treatment of TD in both men and women collected over 7 years. METHODS: This was a retrospective review of data collected prospectively from men and women from 2012 and 2019...

Bioidentical hormones have the exact same chemical and molecular structure as hormones that are produced in the human body. Bioidentical hormones are available as FDA-approved hormone formulations. Nonapproved custom-compounded preparations are marketed as bioidentical, but content is uncertain. The widespread use of compounded bioidentical hormone therapy despite the lack of evidence to support its safety and efficacy is concerning. This Practice Pearl highlights the 2020 recommendations from the National Academies of Sciences, Engineering, and Medicine regarding the use of compounded bioidentical hormones...

CONTEXT: This mini-review provides an overview of menopausal hormone therapy (HT) and cardiovascular disease (CVD) risk, with a focus on the role of hormone formulation, dose, and route of delivery. METHODS: This summary is based on authors' knowledge in the field of menopausal HT and supplemented by a PubMed search using the terms "menopause hormone therapy," "transdermal," "estradiol," "conjugated estrogens," "bioidentical," "cardiovascular disease," "lipoproteins," "glucose," "progestogens," "low dose...

This represents part two of a two-part article on the topic of gender bias within hormone replacement therapy and the well-orchestrated attempt by the pharmaceutical industry to eliminate bioidentical hormones, as well as to downplay the important role of compounding pharmacies in fulfilling the needs of women in this longstanding gender gap. Part one of this two-part article was published in the November/December 2020 issue of the International Journal of Pharmaceutical Compounding...

After the results of the Women's Health Initiative trials were published, patient and clinician interest in potential alternatives to conventional hormone therapy (HT) has grown. A commonly used alternative therapy involves custom-compounded steroid hormone preparations, formulated by compounding pharmacies. Many postmenopausal women consider the hormones as natural or bioidentical, in contrast to hormones used in conventional HT, which they consider synthetic. In actuality, the chemical structures of many of the hormones used in bioidentical HT (BHT) are the same as those used in conventional HT...

OBJECTIVE: To review the efficacy, safety, and available literature regarding the novel combination bioidentical product Bijuva, or 17β-estradiol/progesterone (17β-E/P), for the treatment of moderate to severe menopausal symptoms in cisgender females with an intact uterus. DATA SOURCES: Literature searches of both PubMed (1966 to October 2020) and Google Scholar were conducted using search terms including bioidentical, estradiol, progesterone, menopause, E2/P4, TX-001HR , and Bijuva ...

No abstract text is available yet for this article.

Every woman, if she lives long enough, will transition into menopause, and as the US population ages, women will be spending more time in a postmenopausal state than before. For postmenopausal women, the decision to initiate menopausal hormone therapy should be individualized. A thorough evaluation of the patient's cardiovascular, venous thromboembolic, cancer, and fracture risk should be considered along with the woman's quality of life. Hormone therapy exerts its therapeutic effects on vasomotor symptoms, the skeleton, and the genitourinary system independent of age since menopause and these benefits are lost once hormone therapy is stopped...

Gender bias within hormone replacement therapy has been prevalent for decades, and the circumstances surrounding this bias continue to worsen. A billion-dollar industry has been built on dozens of testosterone replacement therapies and medications to treat andropause and erectile dysfunction for men; women have been less fortunate. This article discusses this bias and the well-orchestrated attempt by the pharmaceutical industry to eliminate bioidentical hormones, as well as to downplay the important role of compounding pharmacies in fulfilling the needs of women in this longstanding gender gap...

No abstract text is available yet for this article.

One of the defining moments of the 80-year evolution of menopausal hormone therapy (MHT) was the 2002 reveal of the initial results of the combined hormone therapy arm of the Women's Health Initiative (WHI) clinical trial. The exodus from regulatory approved MHT was prompt and profound and accompanied by a rapid acceleration of the compounding pharmacy 'bioidentical' hormone therapy industry. Compounders had recruited prescribers and promoted compounded bioidentical hormone therapy (cBHT) well before the WHI, yet the startling results provided a catalyst that enabled a leap in production of compounded hormones that were variably regulated, basically unstudied, and inconsistently labeled...

No abstract text is available yet for this article.

Uterine bleeding is a common reason why women discontinue menopausal hormone therapy (HT). This systematic review compared bleeding profiles reported in studies for continuous-combined HT approved in North America and Europe for moderate to severe vasomotor symptoms in postmenopausal women with a uterus. Non-head-to-head studies showed that uterine bleeding varies by formulation and administration route, with oral having a better bleeding profile than transdermal formulations. Cumulative amenorrhea over a year ranged from 18 to 61% with oral HT and from 9 to 27% with transdermal HT, as reported for continuous-combined HT containing 17β-estradiol (E2)/progesterone (P4) (56%), E2/norethisterone acetate (NETA) (49%), E2/drospirenone (45%), conjugated equine estrogens/medroxyprogesterone acetate (18-54%), ethinyl estradiol/NETA (31-61%), E2/levonorgestrel patch (16%), and E2/NETA patch (9-27%)...