Compounded Hormone Therapy: Results from a Survey

Safety of Compounded Hormones

What Kind of Estrogen Do You Take?.

Who Uses Compounded Hormone Therapy?

If you are considering taking estrogen or other hormone therapy, are you using ones purchased from chain drug stores or hormone therapy from a compounding pharmacy (C-HT)? Are they the same? Is one safer than the other? What are other women doing?

To answer these questions, the North American Menopause Society (NAMS) conducted an internet survey of 3,725 postmenopausal women between 40 and 84 years of age.

They wanted to understand more about the use of C-HT because they are not FDA approved. Hormone therapy from chain store pharmacies are FDA approved (FDA-HT).

At the peak of the use of estrogen in 2000, 21.6% of women 50 or over used hormone therapy.1 However, in 2002 after the publication of the Women's Health Initiative (WHI) study incorrectly claimed that hormone therapy caused breast cancer and blood clots and heart disease, millions of women stopped using it. I explain how this happened in my new book, The Estrogen Window. Up until that time, the most popular drugs prescribed in the country were conjugated equine estrogen products such as Premarin and Prempro.

But after the WHI reported negative risks from FDA-HT, women of women stopped using it and suddenly they faced many challenges from untreated symptoms.2 As a result women sought out what they thought were safer hormones and there was an increased use of hormones from compounding pharmacies.

At first, the term used bioidentical, which means that the hormone is the same chemical structure as the ones found in the body. However, chemical analysis has found that compounded hormones are not all bioidentical because some of the estrogen becomes altered in the manufacturing process to other forms,3 causing the FDA to consider the word bioidentical to be a marketing term and not a scientific term.4 Also, both FDA-HT and C-HT can contain bioidentical hormones, so they are separated here by where they are purchased.

In this survey, about one-third of women were not sure if their hormones were FDA approved or not. It was estimated that about 31% of women who have used HT took C-HT and about 35% of current users take C-HT. Approximately 42% of C-HT users thought their hormone choice was safer than FDA-HT. C-HT users were more likely to be recommended to use it by a family member, friend, nurse-practitioner, or non-medical source such as a television personality, media figure or internet site.  There was a higher rate of vaginal bleeding among users of C-HT than FDA-HT and there were also self-reported cases of uterine cancer among the C-HT users but not among the FDA-HT users. This may be because topical progesterone is often prescribed from C-HT despite evidence that topical progesterone is not adequate to protect the uterine lining from uterine cancer. 5 The most commonly believed reason why women chose C-HT was that they believed it was natural and that it is safer, neither of which is not the case.6

So in summary, about a third of women who use HT use C-HT, mostly because they think it is safer. But that seems not to be the case. If you do use it and you have a uterus, be sure to have the lining of your uterus checked annually so you can be sure you do not have uterine cancer.

Sources:

  1. Steinkellner AR, Denison SSE, Eldridge SL, et al. A decade of postmenopausal hormone therapy prescribing in the United States: long-term effects of the Women's Health Initiative. Menopause 2012;19:616-621.
  2. Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US office-based physicians. 2000-2009. Menopause 2011;18:385-392.
  3. Bhavnini BR, Stanczk FZ. Misconception and concerns about bioidentical hormones used for custom-compounded hormone therapy. J Clin Endocrinol; Metab 2012;97:756-759.
  4. US Food and Drug Administration. Bio-Identicals: Sorting Myths from Facts. April 8, 2008, FDA Consumer Health Information. Available at: Wren BG, Champion SM, Willetts K, et al. Transdermal progesterone and its effects on vasomotor symptoms, blood lipid levels, bone metabolic markers moods, and quality of life for postmenopausal women. Menopause. 2003;10:13-18.
  5. US Food and Drug Administration. Report: limited DA survey of compounded drug produces. Jun 18, 2009. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155725.htm.

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