Since the Women's Health Initiative (WHI) study came out in 2002, women have been confused about their treatment options for menopause.
Results of the U.S. study showed that women on combined estrogen and progesterone therapy had an increased risk of invasive breast cancer, coronary heart disease, stroke and pulmonary embolism; the treatment, however, was associated with a lower risk of colon cancer and hip fracture.
Results were different for women who had a hysterectomy (removing the uterus). They had significantly increased rates of stroke and blood clots, but a lower risk of breast cancer and hip fracture. All told, though, the total number of hormone-therapy users affected by these risks or benefits were small.
Women were given a lot of confusing data and began to feel that hormone therapy was a "bad" thing.
What is clear is that hormone therapy and its use has significantly changed in the post-WHI era. The marketplace has added to the confusion about the therapy.
Many patients come to me with a book by Suzanne Sommers who, without medical training, is offering advice on the use of hormones. Not a week that goes by without a woman coming in and asking for so called "bio-identical hormones" believing from the popular press that this is a safer, non-drug alternative that "allows [women] to replace our body's estrogen." Many of these products are widely available through the Internet.
Unfortunately, "bio-identical" has become popularly equated to the word natural (defined as neither artificial or pathologic) and, for many people, that means they believe it has no harmful effect.
To health-care providers and scientists, however, bio-identical hormone simply implies these hormones are chemically identical to those produced by women, mostly in the ovaries. Bio-identical hormones can be produced chemically to be exact duplicates of our naturally occurring hormones. In fact, there are many regulated bio-identical hormones on the market such as pharmaceutical-grade estrogens and progestins that physicians use in appropriate instances to treat significant hot flashes of the perimenopause (that period of time leading up to menopause).
A bio-identical compounded hormone is essentially a custom-made recipe containing hormones in differing amounts. They often are turned into creams, gels, liquids or spays so they can also contain several other ingredients to hold the mixture together.
At a recent meeting of the North American Menopause Society that I attended in Nashville, a great deal of attention was paid to this burgeoning field. It is important to remember that such custom compounds are not regulated or approved by Health Canada. So, it's fair to say that no one is keeping close tabs on what is happening to the women who take them.
What's more, it's not clear how much is absorbed by the body -- or if the levels remain consistent. And there is absolutely no data to suggest that these products are of benefit, safe, or even that they lack negative side effects.
As the experts at the North American Menopause Society pointed out, there are no patient inserts, no data on safety or efficacy, no uniform manufacturing standards and no check on the veracity or accuracy of advertising claims.
Even so, readily available saliva test kits have created the illusion that women can measure their estrogen levels at home and that these results can help them decide on their unique dosage. But the evidence shows that salivary levels of hormones do not match blood measurements.
There is no question that a fairly large and new market has been created, using the Internet as well as celebrities. I caution my patients that what they think they are getting might, in fact, not be what they are getting.
The U.S. Food and Drug Administration surveyed 29 such compounded products for quality, sterility, identity, potency and uniformity of content: 34 per cent failed one or more tests and 25 per cent of the compounded hormones failed a potency test.
As a consumer, it is important to be informed and not misled by false claims. As always, it is best to sit down with your physician and make a decision based on your needs with a full understanding of the benefits and risks.
Dr. Marla Shapiro can be seen Tuesdays on CTV's Canada AM.
