Estrogen Series WHI Stopped Prempro Arm of Study
Estrogen Series: Part 3 Premarin and Prempro in WHI
Medications Premarin, natural horse estrogens (CEE), and Prempro, a combination of horse estrogens (CEE) and medroxyprogesterone acetate, were studied in the Women’s Health Initiative (WHI).
The intent of the WHI was to document beneficial effects of these medications on the 3 leading causes of death in women, cardiovascular disease, breast cancer, colorectal cancer; and the leading cause of disease in women, osteoporosis. No bioidentical hormones were studied.
WHI was set up as a prevention study, however, two thirds of the women were 60 or older and 75% had never used hormones before.** In addition, by stopping the trial early, longer term effects were not documented which in other studies found increased incidence of coronary events at one year in the study, actually declined over time.****
An OB-GYN MD once told me the lack of 50-60 year olds in the study was because at the time of recruitment most post-menopausal women 50-60 years old were on HRT and none of them wanted to ever come off HRT. They felt too good.
In 2002, The Prempro Arm of the WHI Study, Was Stopped
Results from the Prempro arm of the WHI study versus controls showed early findings of safety issues which included a small increased risk of breast cancer, heart disease, stroke, and blood clots. There was also a significant reduction in colorectal cancer and osteoporosis.
However, initial negative findings were the only ones making headlines across the world causing mass frenzy and immediate discontinuation of Premarin and Prempro in millions of women. Within 3 months, prescriptions for Prempro decreased drastically by 63% as prescribing practices of physicians changed immediately in the US.**
The aftermath from abrupt discontinuation of HRT precipitated moderate to severe ‘withdrawal’ effects in women, of severe menopausal symptoms. Being in distress from no hormones and distress from feeling their doctors had betrayed them, women asked for “the safer alternative” compounded bio-identical hormones. At this time the FDA approved pharmaceutical bio-identical hormones which had been in use prior to the introduction of Premarin in 1941.* One example are Bio-identical hormone pellets first used in 1939!
The Birth of the Thought ‘Estrogen is bad. It causes Cancer, Strokes, and Blood Clots’.
Because the Prempro arm of the study was stopped, the mantra ‘Estrogen is bad. It causes Cancer, Strokes, and Blood Clots’ was born. This thoughtform and belief was brought to medicine and the public through the media. It continues in the minds of traditional MD’s and lay people today. It is advertised on TV in commercials. The same warnings are placed on all estrogen products whether they be bio-identical (which were never studied in WHI) or Prempro or Premarin. Hence, women read these warnings all the time. The idea that estrogen is bad is accepted as common knowledge. Interestingly, no other medications for women’s menopausal symptoms have been created since 1998.
In 2009, Premarin Arm of WHI Study Was Stopped
The Premarin arm, also know as the estrogen arm, continued for another 6.8 years. The Premarin arm was stopped 1 year earlier than planned because of an “increased risk of stroke and no evidence of cardiovascular protection” in women mostly 60-79 years old who never had hormone replacement therapy prior to age 60!**
“The follow-up of the WHI continued for 13 years, and some results, including an age stratification of the cardiovascular outcomes, were published in the following years. A reanalysis of the WHI trial with new studies and a metanalysis showed the use of HRT in younger women (50–59 years) or in early postmenopausal women (within 10 years of menopausal onset) had a beneficial effect on the cardiovascular system, reducing coronary diseases and all-cause mortality.
Furthermore, a large controlled trial from Denmark (reported in 2012) demonstrated healthy women taking combined HRT for 10 years immediately after menopause had a reduced risk of heart disease and death from heart disease. Unfortunately, these data did not receive appropriate coverage by the media, and the fear regarding HRT has persisted.”**
In addition, they found no increased incidence of breast cancer with Premarin.
So what is the truth? Certainly, data regarding safety of HRT has been and is controversial. My intent is to present you data so you can make your own decisions. We have not yet begun to talk about Bio-Identical Hormones as these were not studied in WHI Study.
SUMMARY TO DATE:
Estrogen’s benefits discussed to date.
- Protects women from getting respiratory viruses including Covid. May also be beneficial as a treatment of respiratory viruses especially with lung involvement because of stimulation of the Estrogen Receptor (ER) https://regenerativemc.com/fearofcovid/
Estrogen’s fears discussed to date. None discussed to date
Prempro Benefits discussed to date. Decrease in colorectal cancer and osteoporosis
Prempro Fears discussed to date.
- Preliminary results from 16,608 women in the Prempro-only arm of the Women’s Health Initiative (WHI) 2002 was stopped due to increased breast cancer risk and lack of overall benefit. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5792205/ https://regenerativemc.com/estrogen/
- Prempro use showed an increase in heart disease, stroke, blood clots and urinary incontinence in women 60-79 who had no prior HRT
Premarin Benefits discussed to date: In women immediately post-menopause there was a decrease in cardiovascular disease. No increase in breast cancer.
Premarin Fears discussed to date: A slight increase in stroke and no cardiovascular protection in women 60-79 who had no prior HRT.
Have an awesome day! Dr D