Women's Health Initiative (WHI)
The Women's Health Initiative (WHI) is a long-term study about the risks and benefits of strategies that may reduce the occurrence of heart disease, breast and colorectal cancer, and bone fractures in postmenopausal women. Between 1993 and 1998 more than 160,000 healthy postmenopausal women aged 50 to 79 were enrolled as WHI participants.
One part of the WHI was a clinical trial designed to study the long-term effects of postmenopausal hormone therapy on heart disease, osteoporosis, and colorectal and breast cancer risk.
The hormone trial had two parts: One part looked at the effects of estrogen plus a progestin HRT (a chemically altered form of the hormone progesterone) in a group of 16,608 postmenopausal women who had a uterus (that is, women who had not had a hysterectomy). This group was given estrogen plus a progestin HRT in the form of the prescription drug, PremPro® .
The progestin component in PremPro® acts in many ways similar to progesterone, but is chemically different. Though they differ by just a few electrons connected to an oxygen atom, they exert powerful differences once inside the body.
The synthetic progestin (as opposed to natural or bio-identical progesterone) causes the ovaries to shut down production of natural progesterone, because the body is being flooded with a synthetic variation of the hormone.
The other part of the study, a group of 10,739 women who had undergone a hysterectomy, was looking at the effects of estrogen alone. For the previous group with an intact uterus, a progestin was given together with estrogen because estrogen alone had been shown to increase the risk of endometrial cancer (cancer of the lining of the uterus). Since the women in the second part had no uterus, they were just given estrogen in the form of the prescription drug, Premarin®.
In each part of the hormone trial, half of the women were randomly chosen to receive hormone pills, and the other half to receive placebos (inactive pills). Neither the study participants nor the researchers knew who was taking the hormones and who was taking a placebo.
Because they provide the most scientifically reliable information, medical studies with this design are considered the "gold standard" in clinical trials. Using randomized, controlled, double-blind tests, they are the most effective in scientifically demonstrating a cause-and-effect connection between a particular treatment or behavior and a medical condition or result.
The WHI Study Was Halted Abruptly in July of 2002 – WHY?
An analysis by members of the independent Data Safety and Monitoring Board (DSMB) that monitors the health of participants during the study discovered that women taking the estrogen plus progestin combination had an increased risk of breast cancer as compared to women taking placebo pills. The DSMB analysis also indicated the overall health risks of taking estrogen plus progestin outweighed the benefits. In addition to an increased breast cancer risk, women in the estrogen plus progestin group had an increased risk of heart attacks, strokes, and blood clots in the lungs and legs.
Hormone replacement therapy (HRT) has been in the news for the past several years, due to the release of these findings from the Women's Health Initiative (WHI) in the United States in May of 2002. Keep in mind that the term HRT here has a strict definition. Many doctors and the public are confused over what is the definition of HRT.
HRT = PremPro (PremPro = Premarin + Provera)
In this instance of the WHI study, HRT was strictly meant to include a combination of estrogen (Premarin®) with a progestin (Provera®). The combined estrogen/progestin drug was called PremPro® .
The combination of estrogen and progestin HRT is not to be confused with the estrogen-only form of HRT. One has to read the results of the WHI very carefully to determine the conclusions made in 2002 were based on the combination of estrogen with progestin (PremPro® ) and not the version of estrogen alone.
Later on, after the WHI clinical trial was halted, an estrogen-only component of the study was begun and followed until 2004. More conclusions were then made about the estrogen-only participation regarding heart disease, blood clots, stroke, ovarian cancer, cognitive dysfunction and dementia.
Provera is Not Natural Progesterone
Special attention should be given to the fact that the progestin component of the HRT (medroxyprogesterone acetate, which is branded under the name Provera®), is NOT the same thing as bio-identical or natural progesterone, produced by a human body. The two are vastly different chemicals.
Provera® has an additional medroxy acetate chemical group added to the original progesterone molecule. This changed the activity of progesterone into something that is not natural and, as the WHI study showed, has caused numerous side effects.
The Provera® component is called a progestin. The word “progestin” means that Provera® can occupy progesterone receptors in some cells, but it is not the same thing as natural progesterone. Wyeth-Ayerst, the makers of Provera®, have done such an incredible marketing job on doctors coming out of medical schools, that doctors were lead to believe that Provera® was the same thing as the natural hormone. But it wasn’t.
Unfortunately, several generations of women have been placed on Provera® or Provera®-like medications in the form of PremPro® or contained as a component in birth control pills. It is this component of HRT that’s caused the problems we are now facing.
What Are the Relevant Findings From This Study?
The study suggests that long-term use (more than 4 years) of HRT increases a woman's risk for heart disease and breast cancer. The bottom line from the WHI study was that the following harmful effects were caused or shown to have an increased risk as a result of using HRT:
Combination of estrogen with progestin results in:
- Increased risk of coronary heart disease
- Increased risk of heart attacks (myocardial infarctions)
- Increased risk of lung clots (pulmonary embolism)
- Increased risk of breast cancer
- Increased risk of stroke
- Increased risk of blood clots
- Increased risk of impaired global cognitive function (thinking ability)
- Increased risk of Alzheimer’s Disease
The following were the good things that the combination of estrogen with progestin showed:
- Decreased risk of colon cancer
- Decreased risk of bone fractures
As you can tell, the negative implications were far worse than the positive outcomes.
Women’s Health Initiative – Part 2 – Estrogen Alone
After the study was halted, a new study was begun to investigate the effects of estrogen alone HRT. The progestin (Provera®) was removed and so the only medication left was the Premarin® component. This study was followed from 2002 until 2004, with the results released in 2004 showing the following results:
Estrogen alone study results:
- Increased risk of Alzheimer’s Disease
- Worsened cognitive function (thinking ability)
- Increased risk of blood clots
- Increased risk of stroke
- Increased risk of problems with gall bladder disease
- Increased risk of uterine cancer
- Increased risk of ovarian cancer
There was some slight good news:
- Absolutely helps in alleviating hot flashes, night sweats and vaginal dryness
What Have We Learned?
The scientific and medical world seem to be concerned with the effects of only certain prescription drugs on a woman’s health. Specifically, the three main drugs are under question:
Premarin® (estrogen)
Provera® (medroxyprogesterone acetate)
PremPro® (combination of Premarin® and Provera®)
All of these are made by Wyeth-Ayerst. Wyeth-Ayerst has obviously lost tremendous amount of money in drug sales as a result of WHI findings. Sales of Premarin® plummeted from $1.3 billion in 2002 when the news first broke, to only $850 million in 2005.
All of the hype is over these prescription drugs which are largely foreign substances to the human body. For example, Premarin® is made from a mare’s horse urine! There are about two dozen or so different kinds of estrogens found within this product. Only three of them are compatible with human estrogen: estrone, estradiol and estriol.
Provera®, as mentioned above is actually a chemically converted compound which was converted from a true progesterone to a chemical that could be patented as a drug. It is found nowhere in nature and is not bio-identical to human progesterone.
PremPro® is simply a combination of Premarin® and Provera®.
What no one appears to be asking is simply this: “Why exactly are we so concerned about the financial health of the big drug companies and are not focusing our attention on a women’s medical health instead?”
There is a perfectly safe form of HRT that does not involve using any of these dangerous, patented, prescription drugs - manufactured and aggressively promoted by the big drug companies. Why don’t we use bio-identical hormones to replace those hormones whose natural supply in the body has been depleted, either through chemical manipulation or due to the aging process?
Why instead, is the medical community focusing on using chemicals that are not identical in their molecular structure to the hormones in question?
If your car was running low on gasoline, would you replace it with gallons of vegetable oil calling it “a gasoline replacement alternative?” How long do you think your car would continue to run smoothly – or even at all?
The same holds true for using these counterfeit synthetic chemicals prescribed to “replace” low levels of hormones in your body. Why would you want to replenish low levels of estrogen in your body with horse estrogens? Why would you want to replace low levels of progesterone with a chemical that doesn’t even look like progesterone?
Is there any doubt where the side effects noted in the WHI study are coming from?
Admittedly, the Premarin® does have three human estrogens in it already. And it does a remarkable job quenching the hot flashes, night sweats and vaginal dryness. But what about the other two dozen horse estrogens floating around in a human body as a result?
Never Take PremPro or Provera Again
There is absolutely no excuse for any doctor to prescribe Provera® (medroxyprogesterone acetate) or PremPro® (Premarin + Provera) at any time. It is not even close to resembling human progesterone, and the conclusions from the WHI study indicate that the Provera® component of HRT is a really bad apple - causing terrible side effects.
Birth Control Pills are Just Another Form of HRT
Let’s not forget that birth control pills (BCP’s) are just another form of HRT. They too, contain a combination of estrogens with chemically altered progesterone (progestin). The implications for younger women taking BCP’s are ominous indeed. Only the factor of youth appears to be protecting these younger women from the ill-effects of taking BCP’s.
But time will demonstrate that BCP’s are equally as toxic and poisonous to a younger woman’s body - just as much as traditional HRT has been to post-menopausal women.