Bioidentical hormone therapy: a review

Abstract

Objective: The terms "natural" or "bioidentical" hormone therapy (NHT) are used to describe hormone treatment with individually compounded recipes of certain steroids in various dosage forms, including dehydroepiandrosterone, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol. Based on the results of a person's salivary hormone levels, the final composition of the compounded dosage form is individualized to that specific person. Proponents claim that NHT is better tolerated than manufactured products. This paper is intended to review the concept of NHT and to determine whether there is sufficient scientific evidence to support its use.Design: A literature search was performed in Medline using the following MeSH terms and key words: drug combinations; progestational hormones; hormone replacement therapy; endometrium; estrogen replacement therapy; climacteric; menopause; estradiol; estrogens; progesterone; drug monitoring; and drug compounding. Current Contents, International Pharmaceutical Abstracts, Cochrane Database of Systematic Reviews, Lexis Nexis, Google, Medscape, MD Consult, and clinicaltrials.gov were searched with key words.Results: There are a few observational studies and clinical trials comparing conventional hormone therapy with bioidentical hormone therapy. Studies generally lacked adequate study design, including small sample sizes and comparison of inequivalent doses, to prove safety and efficacy. Little evidence was found to support individualized hormone dosing based upon saliva hormone concentrations.Conclusion: Evidence suggests that, although individualized hormonal products may decrease some symptoms of menopause, it seems they have no proven advantage over conventional hormone therapies and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.

Ethical problems with bioidentical hormone therapy

“…15 Wright's 'bioidentical' phrasing was used by the BHRT prescribing community as a way to promote to patients presumed differences between conjugated equine estrogen and progestin-the hormones used in the WHI study-from BHRT formulations of estrogen and progesterone, which were promoted as safer than FDA-regulated preparations, despite no evidence for this claim in the peer-reviewed literature. 1,2,13,16 When celebrity author Suzanne Somers published a popular book, 17 she introduced the term 'bioidentical' into the popular press and patient population; it has thus become a poorly understood new adjective in the field.…”

“…Regardless of formulations, hormone therapies using estrogen and progesterone are presumed to carry similar risks. 1,2,13,16,18,40 'Big pharma' conspiracies Patients read in popular books and on the Internet that information about the benefits of BHRT is being kept from the public by pharmaceutical companies to protect their market. 19,21,41 The disturbing history surrounding HRT marketing and unpublicized safety concerns 16,42 are misused by some BHRT advocates as evidence to back up this conspiracy theory, even though such statements are made on commercial websites that sell BHRT-related products or books.…”

“…2 BHRT is often prescribed to individuals based on the analysis of a person's salivary hormone levels, however these tests are criticized for being unreliable because there is no correlation between symptoms and hormone levels. 1,2,18 For these reasons, dosing of FDA-regulated female hormone preparations is typically based on providing symptom relief. Clinical ethical problems could result when salivary tests persuade asymptomatic women into taking hormones they may not need, and symptomatic women into taking higher doses that could pose greater risks.…”

“…Bioidentical hormone replacement therapy (BHRT) is defined by Boothby et al 1 as 'hormone treatment with individually compounded recipes of certain steroids in various dosage forms, including dehydroepiandrosterone, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol y the use of the term 'natural' refers to steroid hormones occurring naturally in women and does not refer to phytoestrogens or similar substances.' Fugh-Berman and Bythrow 2 state that bioidentical hormones, a 'pseudoscientific neologism y refer to endogenous hormones, including estriol, estrone, estradiol, progesterone, testosterone, DHEA, thyroxine, and cortisol [which are] synthesized or semisynthesized.'…”

Bio-Identical Hormones: Estrogen and Progesterone: Review

“…3 İleri sürülen sav, sentetik olmayan, aksine vücutta yapılan doğal hormonlara özdeş, bireyin gereksinim duyduğu dozda, arzuladığı kullanım formunda, böylece daha etkili ve yan etkiden ari, aynı zamanda ucuz, âdeta sipariş üzerine üretilmiş alaşımlar sunmaktır. 4 Hatta, güvenli dolaşım dü-zeylerinin dar olduğu hormonal tedaviler için kadının kan, idrar, hatta tükürük örneklerinde hormon düzeyini ölçerek gereksinimine göre alaşım hazırlamak uygulama pratikleri arasındadır.…”