The Controversy of Hormone Replacement
Hormone replacement for women initially started with using hormones chemically different than those made by the human body, referred to as Synthetic hormones. Bioidentical hormones are chemically identical to those made by the human body. Only Synthetic hormones are patentable, and therefore manufactured by pharmaceutical companies. Although synthetic hormones are marketed as safe, they have repeatedly been shown to cause harm. Whenever there is a report of some harmful effect of hormones, it has always been from Synthetic hormones, but the distinction is never made public. Unfortunately, Synthetic hormones are still being widely prescribed.
Background for Hormone Replacement
Synthetic hormones were routinely offered for perimenopausal and menopausal symptoms since the 1960’s. The medical literature provided strong evidence for the use of estrogen and progesterone for women’s health and wellness, most specifically the cardiovascular system and bone health. Our medical knowledge was based on bioidentical hormones (molecularly identical to what the human body makes). However, mainstream physicians continued to prescribe synthetic hormones, not bioidentical hormones because that is what they were trained to do. The pharmaceutical industry manufactures synthetic hormones, which are created by altering the molecular structure of the original hormones, which unlike bioidentical hormones can be patented. The pharmaceutical industry heavily influences what is taught in mainstream medicine.
WHI Study – Hormone Section
The groundbreaking events in hormone history were the initial results of the Women’s Health Initiative Study (WHI Study) in 2002. These results not only made hormone replacement controversial but created an enormous confusion among healthcare professionals, which still has not been clarified.
The hormone part of the WHI study involved about 28,000 women. The goal was to see the benefits of estrogen and progesterone, specifically for cardiovascular health. There was a pre-existing concern of estrogen having an in breast cancer, even though there has never been any credible evidence.
Over 2/3 of the women were above age 60, about 1/4 were above age 69. Of note, the average age of menopause is 51. Perimenopause occurs about 10 years earlier, at which time hormones start to decline.
Women were divided into two main placebo-controlled groups. One group (consisting of women with no uterus) was assigned to synthetic estrogen (Premarin). The other group (consisting of women with a uterus) was assigned to Prempro, a combination of synthetic estrogen (Premarin) + synthetic progesterone (Provera). The federal government funded the study and the participants were monitored in the top 40 US clinical centers. Wyeth-Ayerst, the manufacturers of Premarin and Prempro donated these synthetic hormones for the study.
The Prempro (synthetic estrogen + synthetic progesterone) arm of the study was halted in 2002 due to an increase in blood clots and increase in breast cancer.
The Premarin (synthetic estrogen) arm of the study was halted in 2004, due to an increase in blood clots. No increase in breast cancer was seen.
There was a lot of discussion on the lack of cardiovascular protection, but it was not discussed or clarified that the increase in blood clots (leading to heart attacks, strokes and clots in the lungs) was not due to estrogen itself, but the fact that estrogen was given by mouth. Estrogen given by mouth is a well-known risk blood clots. Another irresponsible aspect of the study was that estrogen was given by mouth to women who had been in menopause for 10-15 years, which itself is a poor state of health.
Conclusions from the Hormone Part of the WHI Study
- The Prempro (oral synthetic estrogen + synthetic progesterone) arm had increased breast cancer and increased blood clots
- The Premarin (oral synthetic estrogen) arm had increased blood clots, but a DECREASE in breast cancer
- Synthetic progesterone, NOT synthetic estrogen was associated with an increase in breast cancer
- It is important to recognize estrogen by mouth is a well-known risk for blood clots
What We Already Knew
- Again, oral estrogen (synthetic or bioidentical) causes an increased risk of blood clots due to the first pass effect of the liver, a well-known effect, which has also been declared on every package insert of oral birth control pills for decades.
- The molecular structure of synthetic progesterone is significantly different than our own (bioidentical) progesterone. Our own progesterone is believed to be protective to our breasts.
Studies Been Done on Hormones Since the WHI Study
The Kronos Early Estrogen Protection Study (KEEPS) was initiated after 2002. Although, the primary focus was on heart disease, there have been no reports of increase in breast cancer.
- No study to date has shown a link between any form of estrogen and an increase in breast cancer. If there were any studies before the WHI study showing a link between estrogen (in any form) and breast cancer, it is unlikely that the hormone part of the WHI study would have taken place. Everyone, including Wyeth-Ayerst, the manufacturers of Premarin and Prempro, would have far too much to lose.
- No study has ever been done on bioidentical hormones. There is no financial incentive.
- Synthetic Progesterone is the only hormone shown in studies to be linked to an increase in breast cancer. First from the British data (Million Women’s Study), then from the WHI study.
- Bioidentical Progesterone has long been believed to be protective for the breast, but again, has never been studied.
- Oral estrogen causes an increased risk of blood clots, which can present in many ways such as heart attacks, stroke, pulmonary embolism etc. This information has been known for decades.
- Women have an inherent risk of breast cancer, which escalates after menopause and continues to increase with age. Without a family history of breast cancer, women have ~ 10% lifetime risk of breast cancer. The risk of breast cancer is about 1 in 233 in the 30’s, and 1 in 8 at age 85. Risk is much higher if there is a family history of breast cancer.
- It is unlikely we will ever studies on bioidentical hormones. Most likely, years from now, we will retrospectively analyze the data on women who used bioidentical hormones. The women of this generation can only make educated choices.