Tulsa BioIdentical Hormone Replacement Therapy (BHRT) – A Look At The WHI

Postmenopausal women can benefit from Tulsa Bioidentical Hormone Replacement Therapy (BHRT). However, there has been a lot of negative information about hormone replacement in general. This post will provide some information about from where some of the negative information came.

I grew up in Tulsa, OK and I recall my mother taking Premarin when she was going through menopause. If memory serves me correctly, she was actually on PremPro which is a combination of Premarin (conjugated equine estrogen) and Provera (Medroxyprogesterone acetate). When my mother was going through menopause most Tulsa doctors were certainly not using bioidentical hormone replacement therapy (BHRT).

Tulsa Bioidentical hormone replacement therapy (BHRT) wasn’t something that was done for many years. Once I left active duty military I wanted to come back home to Tulsa and I saw a huge need for BHRT here.

I began learning everything I could about bioidentical hormones as well as the risks and benefits. I recall a lot of controversy about the benefits of hormones in general but I hadn’t really heard about bioidentical hormones at that time. There was some observational information about benefits of hormone replacement in preventing cardiovascular disease, fractures, and some cancers.

There was a large study that was coming out about the time I was graduating from Medical School. The study was known as the Women’s Health Initiative (WHI) and was started in 1991. The primary outcome of the study was cardiovascular disease prevention in women using hormone replacement post-menopause. The WHI was one of the largest US prevention studies of its kind and consisted of 3 major components:

1. A Randomized Controlled Trial (RCT) of “promising but unproven approaches to prevention.” There were 3 sections of this part of the study:
   1. Hormone Replacement – there were 27,347 post-menopausal women enrolled in this section.
   2. Dietary modification trial – there were 48,835 women in this section
   3. Calcium/Vitamin D supplementation trial – 36,282 women
2. An observational study to identify predictors of disease.
3. A study of community approaches to developing healthful behaviors

The main focus of my discussion here is on the hormone replacement section of the WHI. There were 2 types of hormone replacement given depending on if the women had a hysterectomy (didn’t have a uterus) or not. Neither of these groups were using bioidentical hormone replacement therapy (BHRT). It has long been held that women without a uterus did not need progesterone to counterbalance the effects of estrogen.

Premarin (Conjugated Equine Estrogens)

Let me be clear about one thing. Premarin is NOT bioidentical estrogen. The estrogens in Premarin are not the same estrogens as those naturally in the human body.

The human body contains 3 estrogens:

• Estrone
• Estradiol
• Estriol

Premarin, on the other hand, consists of a series of estrogen compounds:

• sodium estrone sulfate (49.3%)
• sodium equilin sulfate (22.4%)
• sodium 17a-dihydroequilin sulfate (13.8%)
• sodium 17a-estradiol sulfate (4.5%)
• sodium 8,9-dehydroestrone sulfate (3.5%)
• Sodium equilenin sulfate (2.2%)
• sodium 17b-dihydroequilin sulfate (1.7%)
• sodium 17a-dihydroequilenin sulfate (1.2%)
• sodium 17b-estradiol sulfate (0.9%)
• sodium 17b-dihydroequilenin sulfate (0.5%)
• sodium 8,9-dehydroestradiol sulfate (<0.5%)
• Other steroid hormones including androgens and progestogens

As you can see, there are a whole list of chemicals that are not normal and natural in the human body and are, therefore, not bioidentical hormones.

In any case, women who did not have a uterus were randomized to one of two groups: the control group (took a placebo) and the test group who took Premarin 0.625mg daily. These women ranged from 50-79 years of age.

The study was intended to identify the risks and benefits of Premarin (estrogen replacement) on other health factors. The study was intended to stop in 2005. However, the investigators felt that they had enough information and elected to stop the study in early 2004 due to the increased risk of stroke.

The findings of the Premarin group were:

• Cardiovascular disease – there was no increase nor decrease in risk of heart attacks
• Stroke – there was an increased risk of stroke with 8 more cases of strokes per 10,000 women in the Premarin group compared to the placebo group. The investigators felt that this slight but significant increased risk did not warrant allowing the study to continue
• Fracture – there was a decreased risk of hip fracture in the Premarin group
• Breast Cancer – there was no statistically significant difference. In fact, there were 6 LESS cases of breast cancer per 10,000 women who were on Premarin. Interesting! The investigators even stated “what is clear now is that, overall, postmenopausal women without a uterus who choose to take estrogen-alone do not have an increased breast cancer risk, at least over the first 7 years of treatment.”
• Blood clots (venous thromboembolic events – VTE) – there was an increased risk of blood clots in the Premarin group
• Colon Cancer – there was no difference between the Premarin group and the placebo group.

PremPro (Premarin plus Provera)

This is where the women really started having problems. To be clear, Provera is NOT progesterone. It is a progestin. That means that it has some progesterone type effects but it also behaves differently in the human body. Provera is also known as Medroxyprogesterone Acetate (MPA).

16,608 postmenopausal women ages 50-79 were enrolled in the study. Women who had never had a hysterectomy (still had their uterus) were randomized to receive either placebo or PremPro 0.625mg/2.5mg. The plan was to continue the study for 8.5 years.

The findings of the PremPro group were [2]:

• Cardiovascular disease – there was an increased risk of CVD with a Hazard Ratio of 1.29.
• Stroke – there was an increased risk of stroke with a Hazard Ratio of 1.41.
• Fracture – there was a decreased risk of hip fracture with a Hazard Ratio of 0.66.
• Breast Cancer – there was an increased risk of breast cancer with a Hazard Ratio of 1.26.
• Blood Clots (VTE) – there was an increased risk of Pulmonary Embolism (also a VTE) with a Hazard Ratio of 2.13.
• Colon Cancer – there was a decreased risk of colon cancer with a Hazard Ratio of 0.63.

Hazard Ratio = the relative risk of a given event for patients taking PremPro. For example, there was a 26% increased risk of breast cancer in patients taking PremPro.

This portion of the study was stopped early due to an increased risk of breast cancer. They intended to continue the study for 8.5 years but stopped at 5.2 years (3.3 years early) due to this risk. I think it is important to understand that the risk of breast cancer was not increased the in the estrogen alone group but in the estrogen plus medroxyprogesterone acetate group.

The HERS study also showed increased risk of blood clots and no reduced risk of cardiovascular disease. Therefore, they did not recommend using PremPro. [3]

Also of note in the HERS study, PremPro lowered LDL cholesterol 11% and increased HDL cholesterol 10% yet there was no difference in cardiovascular events. The is further evidence that cholesterol does NOT cause heart attacks.

What the WHI Tells Us About Tulsa Bioidentical Hormone Replacement Therapy (BHRT):

What does it tell us about BHRT?

Absolutely nothing!

How can I say this?

First, let me tell you a story. In 2000 the National Highway Traffic Safety Administration launched an investigation into Ford Motor Company and Firestone tires. 823 people were killed due to a combination of the handling characteristics of the Ford Explorer and an issue with tread separation on their Firestone tires. The combination resulted in unstable handling characteristics. Both the Firestone tires and the Ford Explorer played roles in these fatalities.

The problem was not with tires in general. And the problem wasn’t with SUVs in general. The problem was with that specific tire manufacturer and that specific vehicle. It is not appropriate to say that all tires were a problem and you can’t say that all SUVs were a problem because that just isn’t accurate.

I think this paints an excellent foundation for understanding why using Premarin and PremPro (as in the WHI), which are non-bioidentical hormones, are simply not the same as using Tulsa bioidentical hormone replacement therapy (BHRT). There are dramatic differences between the tires as well as these hormones.

I’ll have more information about Tulsa bioidentical hormone replacement therapy (BHRT) in another post. The bottom line, Tulsa bioidentical hormone replacement therapy (BHRT) is a safe and effective way to both treat postmenopausal symptoms as well as optimize overall health and reduce risk of other diseases.

References

1. https://www.nhlbi.nih.gov/whi/
2. Writing group for the Women’s Health Initiative Investigators. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, Principle results from the women’s health initiative randomized controlled trial. JAMA. 2002;288(3):321-333. doi:10.1001/jama.288.3.321.
3. Hulley S, Grady D, Bush T. et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA.1998;280:605-613.