Bioidentical Hormones May Help Prevent Heart Disease and Stroke

Women have been using natural hormones for well over a decade, but until fairly recently there hasn’t been good, solid scientific research showing that it is safe and effective. Yes, there are hundreds of studies that point indirectly to how well natural hormones work, and yes, there are hundreds of thousands, if not millions of women who can attest to how much better they feel using natural hormones. But we would like to see all women have the choice of using natural hormones. The way to get more doctors on the natural hormone bandwagon is to have more clinical research, which means doctors prescribing natural hormones to women and formally tracking the results.

In France and other parts of Europe, women have been using natural progesterone and estradiol (a natural estrogen) in pill form, for about a decade. There are several large and excellent studies of these women which provide solid evidence that it is a safe and effective combination. In contrast, these same studies show that the synthetic progestin hormone replacement (HRT) combinations have numerous harmful side effects, including an increase in stroke, breast cancer and heart disease.

Bioidentical Hormone Heroes

Clinical studies are very expensive, and as a result nearly all published clinical research done in the U.S. is funded by pharmaceutical companies. The drug companies are not sponsoring natural hormone research because they have no interest in selling natural hormones, which cannot be patented. In the U.S. most natural hormones use is transdermal, meaning they are in creams that are applied to the skin. Clinical research on transdermal hormones has fallen to a few courageous and inspired doctors who are willing to devote enormous time, money and energy to conduct small studies. They have to overcome the resistance of their local hospital boards, scrounge up funds, and ask for free testing and materials. They have to interview hundreds of women to find a few dozen to qualify for a small study, and talk them into participating for free. They convince staff and students to help them make phone calls, keep records and crunch data in their off hours. These devoted doctors are indeed true pioneers and heroes whose hard work and dedication will ultimately benefit millions of women for decades to come.

One of those courageous and inspired researchers is Dr. Kenna Stephenson, who recently presented the first-year results of her CHOIICE (Compounded Bioidentical Hormones: Immune, Inflammatory, and Cardiovascular Biomarker Effects) study to the American Heart Association 2008 Scientific Sessions. Dr. Stephenson did her research under the auspices of the University of Texas Health Science Center. She is currently an Associate Professor of Family Medicine at The University of Texas Health Science Center in Tyler, Texas.

The CHOIICE Study Will Give Women More Options
The goal of Stephenson’s three-year CHOIICE study is to measure some important thrombotic (stroke) risk factors in women using transdermal estrogen, progesterone, and androgen (DHEA, testosterone) therapy in peri/postmenopausal women. We already know that conventional HRT (e.g. PremPro) increases the risk of stroke, and the question is, do natural hormones have the same effect?

The CHOIICE study is particularly unique because it does not administer a one-dose-fits-all strategy, which is typical of most studies. Rather, each women’s hormone levels were evaluated at the beginning of the study with saliva tests, and hormones were prescribed accordingly.

What the CHOIICE Study Measured

Hormone Levels, including progesterone, estrogen, testosterone, DHEAS, and cortisol.

Fibrinogen, a protein found in the blood that plays an important role in blood clotting. High fibrinogen levels increase the risk of stroke, atrial fibrillation (rapid heartbeat), intermittent claudication (pain in the legs when walking), and high blood pressure.

Factors V, VII and VIII, blood clotting factors. High levels are a well-established risk factor for stroke.

C-Reactive Protein (CRP), an indicator in the blood of inflammation. High CRP levels are strongly associated with an increased risk of heart disease and stroke.

Clinical parameters, including blood pressure, pulse pressure and body mass index (BMI).

Indicators of Metabolic Syndrome, including fasting glucose, fasting insulin and fasting triglycerides.

Indicators of mood, including the Hamilton Depression/Anxiety Score, the Greene Climacteric Scale and a Pain Scale.

Who Participated in the Study and What They Were Treated With
According to Dr. Stephenson, “The women chosen to be in the study were perimenopausal and postmenopausal, between the ages of 30 and 70, and were free of any severe chronic diseases. They could not be on a statin or other cholesterol-lowering drugs, they could not be on a COX-2 inhibitor, they could not be on any hormones, and had to be cancer-free for five years.” There were 70 women in the study group, and 75 women in the control group (were not treated).

The women’s hormone levels were measured with saliva tests when they entered the study, and those in the treatment group were given bioidentical hormones according to their individual needs. A compounding pharmacy made up a hormone cream for each woman. You can read in more detail about Dr. Stephenson’s approach to testing hormones and prescribing them in her book Awakening Athena, which is available on amazon.com.

CHOIICE Results Point to New Approaches in Women’s Health
The results of Dr. Stephenson’s research should give doctors and women more confidence about using bioidentical hormones. All of the parameters measured either stayed the same or improved, especially in the postmenopausal women.

Dr. Stephenson emphasizes that, “The most compelling thing about the study results that I can share as it relates to women’s health and assessing women in this age group, is that when they visit a doctor with complaints that point to heart disease and stroke, it is vital to know their hormone profile. Starting treatment with pharmacotherapy [drugs] to lower blood pressure, triglycerides or blood sugar may create problems with drug interactions or side effects, or not have global protective effects. By knowing a woman’s hormone profile and her hormone status, and by testing and treating that first, you may see a significant improvement in her blood pressure, her lipids and her glucose.”

We’ll report back next year when Dr. Stephenson has more results from the third year of the CHOIICE study! In the meantime, if you’re interested in the details of the current round of results, you might enjoy this Women In Balance Interview with Kenna Stephenson, M.D.