After the end of the Women’s Health Initiative and the publication of Suzanne Somers’ book titled The Sexy Years: Discover the Hormone Connection: The Secret to Fabulous Sex, Great Health, and Vitality, for Women and Men, bio-identical (bioidentical or bio identical) hormone replacement therapy (BHRT) suddenly became what many people considered a safer alternative than menopausal hormone therapy (MHT) drugs. Since that time people have also asserted bio-identicals provide numerous health benefits, such as reducing hormone imbalances, and that part of the reason is because they are identical to hormones made by the body. There are also claims bio-identicals prevent or cure diseases, such as breast cancer. So, what’s the real scoop on the bio-identical, and should all women be using them?
What are Bio-identicals?
Bio-identicals have been around for a long time, and bio-identical estrogens include estriol, estrone, and 17 beta-estradiol, whereas bio-identical progesterone is just progesterone. Bio-identicals are also manufactured in labs from plants with the specific intention of matching human hormones exactly, and, in fact, according to Advance for Nurses Practitioners, they contain “the exact molecular structure as hormones made in the body.” MHT drugs, also called “synthetic” hormones, are also primarily made from plants, although Prempro and Premarin come from pregnant mares’ urine. However, in comparison to BHRT drugs, MHT drugs are chemically changed so manufacturer’s can patent them, and, in reality, if you’re a stickler neither bio-identicals or synthetics are more “natural” than the other because technically anything that is plant, animal, or mineral is considered “natural.”
Can Bio-identicals Help?
Now you are probably wondering, are bio-identicals better than MHT drugs because they match human hormones? Certain studies and information seems to suggest bio-identicals may have advantages over conventional MHT’s. For instance,
- A study in 2003 showed that when MHT’s are consumed orally there are problems related to blood clotting.
- Another study, published in September of 2004, found that natural progesterone has different risks and benefits than synthetically-produced progesterone.
- Mandie Romero, PhD, and a doctor of pharmacology, published an article in 2002 in the Advance for Nurses Practitioners and she found customized or individualized doses “based on the patient’s individual health profile” probably offer the best approach for hormone replacement therapy.
What Does the U.S. Food and Drug Administration (FDA) Say?
The FDA has several arguments against the use of bio-identicals. They claim they have not approved ANY products with estriol, and that the efficacy and safety of estriol are unknown, and, in fact, according to a senior official at the FDA, Daniel Shames, MD, “No data have been submitted to FDA that demonstrate that estriol is safe and effective.” The FDA also points out that BHRT drugs have not been proven to reduce the risk of getting blood clots, heart attacks, strokes, breast cancer, or gall bladder disease anymore or less than MHT drugs. However, the FDA states that when taking MHT drugs, women need to take the lowest helpful dose for the shortest period of time.
Another sticking point with the FDA relates to compounded drugs. Compounded drugs are used when a doctor decides a person needs specific hormones in combinations not normally available. According to the FDA, although compounding can be beneficial, there can be problems with drugs designed by doctors and mixed by pharmacies. Problems happen if the doctor doesn’t have a extensive experience with bio-identical hormones, and if the pharmacy isn’t experienced with compounding. Additionally, they claim there is no way to assure the compound is safe, effective, or consistent when it’s compounded. The FDA also maintains that some BHRT compounding pharmacies “make unsupported claims that these drugs are more effective and safer than FDA-approved MHT drugs” and that just because a drug’s compounded doesn’t mean it can prevent or cure ANY disease.
What Do Bio-Identical Supports Say?
Bio-identical supporters claim that menopause should not be treated generically. They argue that bio-identical compounding offers doctors the ability to provide customized treatments to women. Furthermore, supporters assert that pharmacies compounded most drugs up until 1920s and that “pharmacists can source chemicals from licensed chemical supply companies and obtain various hormones in their purest form…and use state-of-the-art equipment with which they can accurately prepare individualized formulas.” Thus, they claim, they can provide more individualized, effective, and safer treatments for women.
Bio-identical supporters also allege bio-identicals are superior to traditional medications and that bio-identicals get a bad wrap for the wrong reasons. For instance, in a medical literature review by Dr. Kent Holtorf, Holtorf claims that natural hormones are superior to their synthetic counterparts. The conclusion is clear…bio-identical hormones are a safe alternative to Premarin and medroxyprogesterone acetate (MPA), marketed as Provera.” There is also the assertion that MHT manufacturers, such as Weyeth, are lobbying the FDA to get the FDA to discourage bio-identicals because it will affect their bottom line. However, supporters of BHRT drugs also note, just like MHT drug supporters, health care professionals should recommend “the lowest effective dosage of…[bio-identical] hormones” and they should not be used indefinitely.
So, What’s the Bottom Line?
Monitoring of any drug—whether it be MHT or BHRT drugs—is needed. Bio-identicals can pose health risks to women just like MHTs, particularly if they are used improperly. For example, if a woman is at risk for cancer, she should not take high doses of estrone or estradiol because there appears to be a greater likelihood cancer will develop. There are other health considerations that may also determine whether BHRT or MHT is right for you. Additionally, Romero points out, a “combination of bioidentical hormones will produce side effects if patient symptoms are not monitored and modification is not made accordingly.”
Whether or not bio-identicals are safer than HRT drugs remains to be seen. European studies seem to suggest bio-identicals are safer than MHT drugs, but there are no clinical studies demonstrating BHRT safety over MHT drugs. Bio-identical drugs also appear to relieve hot flashes and alleviate vaginal dryness, and they appear to be beneficial if doses are safe, effective, and consistent. Therefore, it’s up to each woman to weigh the evidence and choose whether BHRT or MHT drugs or the right one for her, but, keep in mind, you should ALWAYS collaborate with your health care professional to make the best choice.
You should also keep in mind that many menopausal symptoms can often be relieved without drugs, and it is not always necessary to take drugs to prevent symptoms. There are a number of dietary, nutritional, supplemental, and herbal approaches that can help many women. In fact, unless your symptoms are extreme, bio-identical or MHT drugs should usually be tried after gentler approaches have either proven unsatisfactory or have not alleviated all symptoms. If you are interested in learning more about herbs and supplements that may help menopausal symptoms, read Menopause Supplements, and, if you are interested in a menopausal diet, read Menopause Diet.