Bio-Identical Hormones: Are They Safe?

by | Oct 17, 2010

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Oprah Winfrey, Suzanne Somers and Robin McGraw (Dr. Phil’s wife) all rave about how “bio-identical hormones have rescued them from menopause.
On her website, Oprah writes, “After one day on “bioidentical” estrogen, I felt the veil lift. After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”
Suzanne Somers has been taking them for years. She believes that the supplements keep her young and feeling sexy and are preventing her breast cancer from coming back.
Robin McGraw says, “I feel better than I ever have in my life,” since starting Bio-Identical Hormone therapy.

What are the Symptoms of Hormone Deficiency?

Hormone deficiencies can cause hot flashes, cold chills, night sweats, sleeplessness, fatigue, lethargy, roller-coaster mood swings, anxiety, irritability, depression, tearfulness, apathy, mental fogginess, difficulty concentrating, confusion, memory loss, vaginal dryness, incontinence, light headedness, weight gain, wrinkles, sagging, thinning skin, osteoporosis and more.
Fortunately, women are now learning that they don’t have to suffer with the symptoms of menopause or resort to taking harmful synthetic hormones. There are safe natural hormone alternatives to the Estrogen-Progestin drugs that are not associated with harmful side effects.

What Are Bio-Identical Hormones?

Bio-Identical Hormones are hormones compounded by pharmacists from natural plant extracts. They are virtually identical to the naturally occurring hormones made by the body, including the three estrogens: estrone, estradiol and estriol, as well as progesterone, pregnenolone, testosterone, DHEA and cortisol.
Because they are identical to what the body makes they are not associated with the severe list of side-effects associated with synthetic hormones.
Because Bio-Identical Hormones come from plants they cannot be patented. In essence, God holds the patent to these plants. That is the only reason drug companies don’t make them. Without a patent, there is no market exclusivity and hence no financial incentive to bring the product to market.

What are Synthetic Hormones?

Synthetic hormones, on the other hand, are altered copies of the body’s naturally occurring hormones. They must be altered in order to qualify for a patent. The chemical structure of these drugs must be altered slightly in order to create a unique chemical not found anywhere else on earth so that it can qualify for a patent.
This altered uniqueness is the distinguishing factor that qualifies them for a patent. The unique chemical structure is similar enough to the original hormone to allow a similar action but unfortunately it is dissimilar enough to cause harmful side-effects.

Balance is the Key to Safe & Effective Bio-Identical Hormone Therapy

There are three types of Estrogen in a woman’s body that work together to safely keep a woman in feminine balance, including Estriol (60-80%), Estrone (10-20%), and Estradiol (10-20%).
Estrone and Estradiol stimulate the cell growth necessary for reproduction. However, when found in too high a level they can induce excess cell growth leading to cancer.
Estriol on the other hand has been found to be anti-carcinogenic and to protect the body from the harmful effects of the Estrone and Estradiol. Estriol has been shown to be anti-carcinogenic.
The correct ratio of Estriol to Estrone and Estradiol as found naturally in a healthy woman’s body is 8:1:1. Taking Estrone, or Estradiol, without Estriol will create a hormonal imbalance that can lead to heart disease, strokes, blood clots and cancer.

Is Natural Always Better?

Just because a hormone is natural, or bio-identical to the body’s own hormones, does not necessarily mean it is safe. Wyeth claims that Premarin is natural. It is extracted from pregnant horse’s urine. It is natural for a horse, but not a woman.
Most importantly, the quantity and balance of the natural hormones prescribed determines whether or not the therapy is safe. Many women get cancer of the breast, ovaries, or uterus from an imbalanced or excessive production of their own Estrone and Estradiol production.
Likewise, the prescription of natural hormones can cause harm if not balanced. Natural, Bio-Identical Estradiol should never be given without also giving natural, Bio-Identical Estriol and Progesterone in order to maintain a woman’s healthy balance.

Drug Companies Copied the wrong Estrogens

The drug companies that made the first estrogen drugs copied the wrong estrogens. They copied the two most concentrated estrogens: Estrone and Estradiol.
This made sense from a production standpoint but not from a safety standpoint. Estrone and Estradiol are 1000 times more potent than Estriol. For this reason Estriol was initially thought of as a weak estrogen.
However, nature puts all three estrogens together for a good reason. Estriol protects the body from developing cancer. If your body has enough Estriol it will prevent the other two more potent estrogens from stimulating the breast and uterus where they tend to cause cancer.
The pharmaceutical scientists made a mistake by underestimating the wisdom of nature’s hormone balance and synergy and ignored Estriol because they considered it a weak estrogen.

Are Bio-Identical Hormones Proven Safe?

There are several good studies on the safety and efficacy of bio-identical hormones, including one large-scale study that compared the risks associated with synthetic and bio-identical hormones. However, even bio-identical hormones can be harmful if they are not prescribed to achieve the appropriate 8:1:1 ratio as it exists in healthy women. For this reason I recommend testing before and after dosing to make sure your levels are optimal. Click here for more information on hormone testing.
In 2005 the Fournier Study published in the International Journal of Cancer followed 54,000 women who took bio-identical estrogen and either bio-identical progesterone or progestin. The women taking the bio-identical progesterone had a 10 percent decrease in the risk of breast cancer while the women taking the synthetic progestin had a 40 percent increase in the risk of breast cancer.
A follow-up article published in 2007 in Breast Cancer and Treatment looked at 80,000 women. Women taking bio-identical estrogen and progesterone had no increase in the rate of breast cancer, while those taking an artificial progestin had an increase of 69% in the risk of breast cancer.
The de Lignieres Study published in 2002 in the journal Climacteric concluded that the risk of breast cancer is not increased with bio-identical hormones but is increased with synthetic progestin.
Bio-identical hormones have been used in Europe for almost fifty years. Since bio-identical hormones are available in relatively inexpensive generic forms that can be applied using non-patentable formulations by a compounding pharmacist, American drug companies have no interest in sponsoring studies on the safety and efficacy of bio-identical hormones.

Estriol is the Key Estrogen for Safety

Estriol is a mild estrogen that has been used in Europe for 30 years. Its safety and effectiveness are well established. Many doctors in the U.S. who use natural hormones prescribe estriol plus natural progesterone to balance the hormones and stop the symptoms of menopause.
Here’s what the medical literature states about Ovestin, a natural, Bio-Identical Estriol made in Europe: “Ovestin contains the natural hormone Estriol, which is a weak estrogen. Unlike other estrogens, estriol is short-acting since it has only a short retention time in the nuclei of endometrial cells.
Estriol prevents hot flashes, bone loss, thinning of the skin and vaginal membranes yet it is 1000 times less stimulating to the breast tissue than is Estradiol. Not only does it NOT promote breast cancer, but considerable evidence indicates that it may protect against and reverses breast cancer.
According to an unpublished study by Lemon, Foley, and Kessinger, “2.5 to 5 mg and occasionally 15 mg of estriol, equivalent to a little more than 0.625 to 1.25 mg of conjugated estrogens and estradiol) was used, with the informed consent of patients, in postmenopausal women with breast carcinoma and metasiases. Thirty-seven percent receiving this small dosage had remission or arrest of metastatic lesions.”
Estriol does not induce excessive build-up of the endometrial lining of the uterus. Hence it does not cause a risk of uterine cancer or withdrawal bleedings.
In addition to treatment of hot flashes, mood swings, and other common symptoms of menopause, Estriol is particularly effective in the treatment of vaginal and urinary symptoms.
In case of atrophy of the vaginal tissue Estriol induces the normalization of the urogenital epithelium and helps to restore the normal microflora and the physiological pH in the vagina.
As a result, it increases the resistance of the urogenital epithelial cells to infection and inflammation reducing vaginal complaints such as painful intercourse, dryness, itching, vaginal and urinary infections, pain on urination and mild urinary incontinence.

What does Dr. Hansen Prescribe to his Patients for Menopause?

The first thing that I do for my patients with symptoms of menopause is to test their individual hormone levels. Balance is the key to optimal health and vitality.
We need to know the starting level of all of the key hormones including Estrone, Estradiol, and Estriol, as well as Progesterone, Pregnenolone, Testosterone, DHEA, Cortisol and Thyroid.
For moderate or severe symptoms of menopause, I recommend Hormone Augmentation with a combination of natural Bio-Identical Estriol and natural Progesterone determined by the individual hormone testing of each individual patient.
Click here for more information on hormone testing

Natural Progesterone

Taking natural Progesterone helps to prevent uterine cancer and increases Bone Mineral Density by as much as 10-15% within 6 months and 20-25% in 3 years (Clinical Nutrition Review, 1990, 10:384-391). The natural bio-identical hormones are safe and effective alternatives to synthetic drugs, providing all of the benefits and more, without the negatives.

Black Cohosh is an Effective Herbal Remedy for Milder Menopause Symptoms

black_cohoshFor mild symptoms of menopause, Dr. Hansen formulated a product that he named Esprogen, which contains five of the best hormone balancing herbs nature has to offer.
The key herb for menopause is known as Black Cohosh (Cimicifuga racemosa). It has been shown to be effective in the treatment of the most aggravating menopausal symptoms, including hot flashes, profuse sweating, sleep disturbances and depressive moods. In a review of eight human studies, it was shown to be a safe, effective alternative to estrogen replacement therapy.
U.S. and European Clinical studies documenting the safety and effectiveness of Black cohosh root extracts for the treatment of menopause are impressive. These studies show good therapeutic efficacy and safety profiles for Black Cohosh root. In addition, clinical and experimental investigations indicate that Black Cohosh root does not show hormone-like activity and may possess anti-cancer activity. (SOURCE: Adv Ther 1998 Jan-Feb;15(1):45-53; Planta Med 1991 Oct;57(5):420-4; J Womens Health 1998 Jun;7(5):525-9, University of Bridgeport, Connecticut, USA)

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