Confusion on the Benefits and Harms of Hormone Supplements
By Grattan Woodson, M.D.
I have surveyed women’s attitudes about hormone use after menopause and discovered that virtually all are misinformed today regarding the benefits and especially the harms of this essential treatment. Hormone therapy has been prescribed for women since the 1950s and in my opinion has been a boon to many. While there have been problems associated with the use of hormones in women after menopause most of these are related to the use of synthetic artificial compounds that simulate the effect of natural bioidentical hormones used orally and in very high dose. These mistakes were ironically a consequence of the pharmaceutical companies needs to patent unique chemical agents in order to profit maximally and it is not possible to patent bioidentical products. They must be chemically singular and that resulted in these companies developing and marketing a plethora of artificial hormones that resulted in significant benefits but at the expense of serious harms.
There have been many studies done of hormones through the years with most of them showing significant benefit of hormone therapy for women after menopause. These were large studies that followed thousands of women for 20+ years. They found that estrogen alone and with and without progesterone prevented heart disease, improved quality of live, and longevity in users of hormones compared to those women who did not use them.
The Women’s Health Initiative WHI was designed to be the definitive study of estrogen therapy in women after menopause. It was sponsored by the US National Institutes of Health to answer the following questions:
- What is the risk for breast cancer in women using hormones after menopause?
- What is the risk for heart attack disease in women using hormones after menopause? What is the risk for stroke disease in women using hormones after menopause?
- What is the risk for pulmonary embolism disease in women using hormones after menopause
- What is the risk for deep vein thrombosis in women using hormones after menopause?
- What is the risk for hip fracture in women using hormones after menopause?
- What is the risk for vertebral fracture in women using hormones after menopause?
- What is the risk for colon cancer in women using hormones after menopause?
The study had very little budgetary support from the NIH but Wyeth the maker of Premarin (CE) and PremPro (CE/MPA) volunteered to donate millions of dollars worth of medication so the study could proceed. Below is a summary table of the actual data with my interpretation.
Women’s Health Initiative Studies Results for the CE/MPA Group (16,000 Women)
|Condition||Increased Annual Risk||Decreased Annual Risk|
|Deep Vein Thrombosis||13/10,000|
The interpretation of the table of risks seen in women taking CE/MPA is as follows: There was an increase risk for breast cancer 0.0008 per year, heart attack or 0.0007 per year, and stroke of 0.0008 per year. Pulmonary embolism is a blood clot that comes from the deep veins of the legs or pelvis. The risk for pulmonary embolism is increased by 0.0008 per year and for deep vein thrombosis 0.0013 per year. The benefits seen in the CE/MPA group include a reduction in hip and vertebral fracture risk of 0.0005 and 0.0005 respectively. Colon cancer risk fell by 0.0006 per year.
As you can see the risks and the benefits from use of CE/MPA in this study was minimal. The overall negative effect size from use of CE/MPA is very small. It is dominated by the two clotting abnormalities pulmonary embolism and deep vein thrombosis that together account for an increase risk of 0.0021 per year. This is due to administering estrogen orally, which increases clotting factor production in the liver. That is eliminated by administering estrogen topically and topical administration also allows the use of a dose 1/10 the size of the oral dose but with the same systemic effect. When the clotting risks are removed from the global risk equation the net risk of using CE/MPA in this group calculated obtained by summing the increased and decreased risks is 0.0007 per year, which in my view is low risk.
There are other ways the risks seen in the WHI can be reduced further. These include administering all the hormones topically rather than orally that avoids the first pass through the liver where 90% of hormones are metabolized. This permits use of 1/10th the oral dose. Using bioidentical hormones rather than artificial hormones like those used in the WHI and by most commercial pharmaceutical manufacturers. These products are what the body is accustomed to and prepared to use and metabolize unlike artificial commercial hormones with longer than normal half-lives and unnatural metabolites.
In comparison, the average lifetime risk of women in there 50s for developing breast cancer is 0.11. If they also used the artificial hormones used above then that would increase her risk by 0.0008 annually. The risk of breast cancer or heart attach with bioidentical hormones is not known and will probably never be studied. In my opinion it is not zero but probably not as high as with synthetic artificial ones. It is not likely in my opinion to place women at higher risk. Suppose it is about half as risky or 0.0004 annually which seems like a fairly conservative assumption in my opinion but that is merely an educated guess not based upon data. We all have different risk tolerances and knowing the facts helps make informed choices. Doing so is important to be comfortable with whatever decision made.