The HRT Controversy: Sorting out the Facts from the Fiction

What Caused the Concern and Confusion over HRT?
Over the years most if not all women going through menopause were encouraged by their doctors to go on some type of hormone replacement therapy (HRT) for their menopausal symptoms like hot flashes, mood swings, insomnia and weight gain. The conventional wisdom was that HRT also prevented heart disease, kept women's skin and brains youthful, made strong bones and had few side effects.

Given that millions of women were taking synthetic hormones, in 1991 a government study called the Women's Health Initiative (WHI) was designed to assess the balance of risks and benefits of synthetic estrogens or a combination of estrogen and progestins (synthetic progesterone) on reducing and/or eliminating certain diseases. The long-term studies in the WHI were initiated because over the years a number of research studies presented a complicated picture of the risks and benefits of hormone therapy, and its continued use for prevention of cardiovascular diseases was controversial.

Although the results from the study were originally scheduled to be released in 2005, the Estrogen-Progestin arm of the study was stopped in July 2002, and Estrogen-alone study was stopped in March 2004. Surprisingly to many in the conventional medical community, the preliminary date of the uncompleted WHI study indicated that synthetic hormones (brand names: Premarin and Prempro) appeared to increase disease in the women being studied, including a 22% increase in heart disease, a 26% increase in breast cancer, a 50% increase in the number of blood clots, and a 41% increase in the incidence of stroke.

The abrupt cessation of the WHI study caused a media frenzy and raised concerns regarding Hormone Replacement Therapy (HRT) by both the professional and lay community. Physicians and patients alarmed by these results decided to discontinue synthetic hormones and began looking for alternatives to their menopausal symptoms. However, women found that as soon as they stopped taking their synthetic hormones, their menopausal symptoms came rushing back. This was terribly discouraging for women struggling to deal with their symptoms but afraid of the health risks of hormone replacement therapy.

As a pharmacy provider for bio-identical hormone replacement therapy (BHRT), with specialized expertise in women's health and menopause, Cox Pharmacy works closely with healthcare providers and helps to educate patients, providing background and perspective on these studies, and information on bio-identical hormone replacement.

All Hormones are Not Created Equal
Healthcare providers and their patients have been left wondering where to turn in the wake of the Women's Health Initiative (WHI) decision to stop part of its study regarding hormone replacement therapy (HRT). Unfairly, the WHI has left the impression that all HRT is the same and poses the same health risks identified in the study. This is simply not the case. There are safe and effective alternatives to the "synthetic" one-size-fits-all dosage form of hormone, which was the focus of WHI.

There are two primary differences between "conventional" hormone therapy (as used in the WHI study) and what we promote as "bio-identical" hormone supplements:

  1. Chemical Structure
    Bio-identical hormones are those that are biologically identical to the hormones found naturally in your body. Their effects are identical to the hormones they are supplementing or replacing. The family of estrogens found in women are Estriol, Estrone, and Estradiol, which occur in approximation of 90%, 3%, and 7%.

    The WHI used the most frequently prescribed HRT products Premarin or Prempro in their study. Premarin is said to contain conjugated equine estrogens(CEE). Premarin is a complex extract of pregnant mares' urine and contains at least 10 estrogens in their sulfate ester form. Unfortunately all most all of the estrogens are foreign to a woman's body. Below is a breakdown of major estrogens found in conjugated equine estrogens:
     
    • Estrone 50-60% (natural to humans and horses)
    • Equilin 23-30% (natural only to horses)
    • Equilenin 13-20% (natural only to horses)
    • Estradiol (natural to humans and horses) and other equine estrogens 2-8% (natural only to horses)
     
    A woman's body has none of the enzymes and cofactors required to metabolize horse estrogens, nor does it have enough of these important substances to deal with the excessively large amounts of Estrone found in Premarin. Therefore it should come as no surprise that the presence of Premarin in the human body induces a hormonal imbalance that can have important adverse consequences.
     
    The WHI also studied Prempro, which contains the conjugated equine estrogens found in Premarin and the synthetic progesterone type product called medroxyprogesterone. Again, the main difference between bio-identical micronized progesterone and the synthetic counterpart is that medroxyprogesterone is merely an analog or "look alike" of progesterone. The synthetic progesterone products are known as progestins. Unlike medroxyprogesterone, natural micronized progesterone is an exact chemical duplicate of the progesterone that is produced by the human body. Natural progesterone duplicates the body's progesterone exactly, causes fewer side effects and can be more consistently utilized by the body.
     
  2. Variable dosing options
    The combination of synthetic estrogen and progestin used in the study conducted by the Women's Health Initiative come in just a few standardized doses. BHRT prescription dosage can be easily customized for each woman's unique needs. Individualization includes testing a woman's current hormone levels, determining the specific combination of hormones she requires, and prescribing at the lowest effective dosage, thereby minimizing unwanted effects. These prescriptions can be administered in a variety of forms including tablets, capsules, patches, and creams. It is important to note that the bio-identical hormones we commonly use in customized compounded hormone prescriptions (including estriol, estrone, estradiol and progesterone) were not part of these studies

The Choice is Still Yours
At Cox Pharmacy we recommend that you not let recent news reports frighten you into automatically abandoning hormone replacement therapy altogether. Instead, let them motivate you to learn all you can so you can make your own, well-informed choice. Decisions about whether to stop, start, or change your HRT should be made on an individual basis only after consulting your physician and a knowledgeable pharmacist. Since studies and the media continue to provide conflicting and confusing information, we are here to help clarify the issues that surround HRT.

The consulting pharmacists at Cox Pharmacy routinely work with women and their health care providers to individualize HRT regimens, and are available to advise you. Please call us at locally at (918) 456-2233 or toll free at 1-866-269-5556. Our trained pharmacy team will be happy to answer any additional questions you may have on bio-identical HRT.


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IMPORTANT NOTICE: Cox Pharmacy is a licensed compounding pharmacy that only engages in compounding in response to a doctor's prescription, and the information contained on this site is general in nature and is intended for use as an educational aid. You should consult your doctor or contact a Cox Pharmacy pharmacist (1-866-269-5556) about diagnosis and treatment of any health problems. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration("FDA"), nor has the FDA approved the products to diagnose, cure or prevent disease.