Revisiting hormone therapy for menopause symptoms

Bioidentical does not equal natural and safe.

Menopause is a natural stage of life that every woman experiences, with symptoms ranging from minor inconveniences to incapacitating symptoms. Over the past decades there have been major shifts in attitude toward the use of hormones to manage symptoms of menopause.

Evolution of hormone use

Until the turn of this century, hormone therapy was commonplace. Then, in 2002, one arm of a large study called the Women’s Health Initiative was prematurely stopped because of results showing an association between hormone treatment and significant disease.

Although we now understand that the interpretations of the study were flawed, at that time many women were advised to stop taking prescription hormones. While patients’ distrust of doctors and the pharma industry grew, the need for symptom relief persisted and a new category of unregulated treatments emerged including custom compounded bio-identical hormones.

Custom-compounded “bioidentical” hormones

“Bioidentical” hormones are almost identical in molecular structure to the hormones made by the ovaries but they’re not found in this form in nature. Instead, they must be synthesized in the lab from a plant chemical extracted from yams and soy.

Compounding pharmacies began to offer custom compounded bioidentical hormones in non-standardized and unregulated combinations as an alternative approach to the vilified prescription hormones. They continue to be in great demand by women who believe they are more natural and effective, safer and have a more positive effect on health.

Myths and facts about custom-compounded bioidentical hormones

There is much misinformation surrounding “bioidentical” hormones. Below are the facts.

Myth: Bioidentical hormones are safer.
Fact: The term bioidentical is a marketing term, chosen to imply natural and therefore safer. In fact bioidentical hormones are not subjected to the same rigorous evaluation process as regulated hormones are, to ensure their safety and effectiveness. It is unknown whether these unapproved bio-identical hormone therapy mixtures are properly absorbed or whether they provide the appropriate levels of hormones needed in the body. It is also unknown whether the active ingredient in each batch of cream or gel is consistent from batch to batch. Serious problems with inadequate absorption of progesterone, resulting in uterine cancer, have been reported with bio-identical hormones.

Myth: The absence of detailed packaging information that warns about side effects of bioidentical hormones means they do not have the same risks as Health Canada approved hormones and are therefore safer.
Fact: Packaging information listing potential side effects of cancer is not legally required for bio-identical hormones, creating a false confidence in their safety. This does not mean they are safer.

Myth: Bioidentical hormones are more natural than Health Canada approved prescription hormones.
Fact: They are no more natural than many Health Canada approved prescription hormones that are also made from plant-based sources such as soy or yam. Both bio-identical hormones and Health Canada approved prescription hormones still need to be commercially processed in a lab to become bio-identical.

Myth: Bioidentical hormones are more similar to the hormones made by the body than Health Canada approved prescription hormones.
Fact: The term bioidentical is meant to mean that the hormones in the product are chemically identical to those that are produced by your body. They are actually the same compounds as many Health Canada approved prescription hormones but prepared and dosed in less regulated ways, not backed by scientific scrutiny.

Myth: Bioidentical hormone therapy dosage can be customized to a woman’s individual needs.
Fact: Specialty clinics claim to offer hormone products that are custom made, based on a saliva test to assess a woman’s unique hormonal needs. The hormone levels in saliva don’t always reflect the levels in blood or even correspond to menopause symptoms. In addition, saliva or blood hormone levels fluctuate on a day to day basis so there is no science behind customizing a dose from a single saliva or blood test.

Use hormones when they are safe

Physicians now understand when and how Health Canada approved hormones should be used, and when they shouldn’t. With a few exceptions, if you are healthy, and less than ten years from your last menstrual period or under age 60, hormones are considered safe to use for up to 5 years.

If you are advised by your physician that Health Canada approved hormones are not appropriate for you, then nonstandard doses and forms of custom compounded hormones may be right for you. That was their intended purpose. But until formal standardization is created, for the vast majority of women they are not.

Dr. Janice Weiss is certified as a menopause practitioner with the North American Menopause Society.

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