Raging (Bioidentical) Hormones

by Brian Dunning
October 16, 2007

Today we're going to take a close look at one of the newer trends in popular medicine: so-called bioidentical hormone therapy, espoused by celebrities like Suzanne Somers and Oprah Winfrey, and by all the usual pharmacological conspiracy theorists who reveal "What your doctor doesn't want you to find out."

Most women know all about hormone replacement therapy, but many guys, especially those without wives who have gone through it, have no clue what it is, so here's the 30,000-foot view. When women go through menopause, their hormone levels can go crazy, often dropping to low levels and fluctuating for several years or sometimes longer. This can produce uncomfortable symptoms such as hot flashes and vaginal dryness. For a long time, hormone replacement therapy has been the standard treatment. Doctors would prescribe HRT, hormone replacement therapy, using synthetic hormones made under close FDA supervision and taken orally in pill form, which is usually successful in treating these symptoms.

But things changed in 2001, when the National Institutes for Health sponsored the Women's Health Initiative, a gigantic clinical trial set up to double-check this standard practice. And guess what they found? Conventional HRT could, in some cases, pose risks that outweighed the benefits. Women taking the most popular HRT, a combination of estrogen and progestin called Prempro, were at greater risk for heart disease, breast cancer, stroke, blood clots, and dementia. Women taking estrogen alone, called Premarin, were at slightly larger risk of stroke.

Now there's your headlines. And when headlines appear, the alternative therapy machine mobilizes. And it did, big time, inventing what it calls bioidentical hormone therapy. The term bioidentical means that these hormones are almost chemically identical to, but do not exactly replicate, those manufactured naturally by the human body. Strictly speaking, bioidentical hormones are and have been available in FDA-approved form already. Estrace, the Climara and Vivelle-dot patches, and Prometrium are all FDA-approved bioidentical hormones that your doctor can prescribe. So if you want to give bioidenticals a try, you can go to your family doctor and ask for them, you don't have to look in the back of some magazine.

But the alternative medicine industry is not FDA approved and has no route to your wallet through your doctor, so they had to come up with something that they can sell over the counter. They chose skin creams and paid celebrity endorsers, most notably Suzanne Somers, the esteemed medical and scientific genius. These are prepared by what's called compounding pharmacies, and contain different forms of estrogen and/or progesterone with different potencies. These are not subject to FDA approval. An FDA study in 2003 found inconsistencies in dose and quality among these products. Since their production and distribution is not regulated or monitored, there is no reason to assume them to be free of impurities or to contain any given dosage.

Nevertheless, a major selling point of alternative bioidenticals is that the dosage is claimed to be customized to each individual patient, usually through a saliva test. Doctors, however, dispute the usefulness of such a test, on the grounds that even with a blood test, which is more accurate than a saliva test, hormone levels vary substantially throughout the day just by normal physiological activity. The second selling point is that bioidenticals are "all natural" and are thus somehow safer and more effective than synthetic versions. Not only is this completely unsupported by evidence, it is a logical absurdity, since the term "bioidentical" means that it is intended to be the very same molecule.

Of the risks uncovered by the 2001 trial, none were found to have been caused by the particular molecular structure of the synthetic hormones. Thus the proper conclusion is that whatever risk is caused by the hormone therapy will be exactly the same whether the hormone is synthetic or bioidentical to the synthetic, assuming the same dosage and purity.

But now let's return to the 2001 trial, past the point where the reporters got their sensational headlines then left the room, and where Oprah stopped reading. First of all, the part of the trial that was stopped due to increased risks dealt only with women with a uterus who were taking Prempro, which was only one of the five major groups in the study. There is no clinical evidence of risks exceeding benefits for women on other programs. The Prempro study was stopped because the study's monitoring board set the level of acceptable risk at an unusually low threshold. Many doctors caution their patients not to panic and abruptly end all treatment, but rather to gradually reduce the dosage to a safer level or switch to a different program. But even this may not be necessary for many patients, since the risks found in the study were correlated to the patient's age, number of years since menopause, and number of years that they had been taking the hormone, so even the worst results do not necessarily apply to many women. These qualifications to the alarmist headlines may not play so well on Oprah and may not spur as many celebrity-endorsed self-medication books, but they are typical of what's found when cooler heads prevail and you allow yourself to listen to the actual science.

Here is what it boils down to. If you are a menopausal woman suffering from symptoms, check with your doctor to find out if you are a candidate for hormone replacement therapy, and to learn whether you are at risk for any of the stated conditions. Suzanne Somers is not your doctor. If you want to go with what you've heard about a dosage customized for your body's hormone levels, get a blood test from your doctor instead of the far less useful saliva test, and ask to understand whether this is a useful indicator of your hormone levels. If you pass your doctor's tests and are comfortable with any risks, and you decide to try hormone replacement therapy, and if you feel that a bioidentical compound is right for you, have your doctor prescribe an FDA approved bioidentical product, rather than buying a celebrity-endorsed unapproved product of unknown purity and origin. And no matter what you do, be aware that your natural hormone levels will fluctuate naturally during this period, so check back with your doctor at recommended intervals.

By Brian Dunning
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