Bioidentical Hormones for Menopause: What Should We Tell Our Patients?

Désirée A. Lie, MD, MSEd

Disclosures

December 15, 2015

Case Presentation

Mrs Miller, a 53-year-old woman who has had no menstrual periods for a year, is troubled by recurrent hot flashes, both day and night, requiring regular change of clothing and awakening her at night. Recently she has also experienced vaginal dryness interfering with intercourse with her husband. Her mood is described as volatile by her husband, and she admits to feeling low at times, with crying spells, though she denies that she is suicidal. She is concerned about the use of estrogen replacement therapy for her menopause symptoms, after having read about the risks for breast cancer and heart disease. She has had two normal pregnancies, has no family history of breast cancer, and had a normal mammogram 6 months ago. She has tried over-the-counter black cohosh and evening primrose oil with no perceived improvement in symptoms over the past 2 months. She is unwilling to start antidepressants. Her friends have recommended the use of bioidentical hormones, and she has read endorsements by celebrities. She asks for your opinion about buying these products online. She is wondering whether they are worth the cost, because her health insurance does not cover them, and if there are side effects.

Bioidentical Hormones

The use of prescription hormone replacement therapy (HRT) or conventional hormone therapy (CHT) has significantly declined since publication of findings of the Women's Health Initiative in 2002.[1,2] Fear of the risks associated with HRT, including breast cancer and cardiovascular disease, have been cited as driving factors in the avoidance of HRT among peri- and postmenopausal women.[3,4] Because of concerns about potential long-term risks associated with estrogen use, postmenopausal women who continue to be troubled by menopausal symptoms now often seek alternative treatments that they perceive to be "safer" or "more natural."[5] As a result, there has been a concomitant rise in the use of bioidentical hormones, often packaged as combinations of hormones including estrogens, progestins, and testosterone.

Despite myriad publications and consensus statements from organizations such as the US Food and Drug Administration (FDA), the American College of Obstetricians and Gynecologists, the North American Menopause Society, the Endocrine Society, the US Preventive Services Task Force, The American College of Clinical Pharmacy, and the American Association of Clinical Endocrinologists[6,7,8,9,10,11,12] calling for caution and more evidence of efficacy and lack of harm, the use of non-FDA-approved bioidentical hormones continues to rise. Consumer websites have proliferated. Some distinguish between FDA-approved and non-FDA-approved bioidenticals,[13] and others point out that although individual ingredients used in bioidentical products may be FDA-approved, the combination of hormones and vehicles in which they are compounded are not FDA-approved.[14] Bioidentical hormone products may also contain plant constituents made from soy or Mexican yam. The practice of using salivary samples to assess product efficacy through hormonal levels is unproven. There remains an absence of large, well-designed randomized controlled trials on non-FDA-approved bioidenticals, in part owing to the variability of hormonal content in these products.[15,16] For example, the estrogenic potency and potential risk for endometrial cancer cannot be assessed.

Compounding the issue, bioidentical hormones marketed through web sites or other consumer portals are generally not covered by health insurance companies, putting women out of pocket if they choose to use these products.

Recent surveys of patients and physicians suggest a high rate of use and prescription of bioidentical products, despite concerns about their efficacy and harm profiles. For example, the recent Harris survey administered to 801 women aged 45 to 60 years estimates that 1 to 2.5 million US women aged 40 years and older are using compounded bioidentical hormones annually. Among them, 1 in 5 women responded that the treatment was "personalized," and that their own physicians recommended the treatment. A second survey, the Rose survey of 2044 women aged 40 years and older suggested that bioidentical hormone use accounts for 28%-68% of hormone replacement prescriptions from physicians and that up to 2.5 million US women may be currently using them. In the survey, 1 in 4 women claimed that their physicians had recommended the bioidentical hormones. A survey of physicians found that almost half of respondents disagreed with recommendations of the North American Menopause Society. One third of those who disagreed were obstetricians, and 58% were family physicians. The most important factors cited for prescribing the products were efficacy and tolerability.

Given the state of knowledge about bioidentical hormone products, with a lack of robust trials to prove efficacy or to assess harm, how should clinicians approach the conversation with their peri- or postmenopausal patients about the use of bioidentical hormones for their symptoms?

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