Results from the Women's Health Initiative Study have led many women to stop their hormone replacement therapy (see related links below). In this article, Dr Michael Goodman, who is a specialist in peri-menopause medicine, takes a critical look at the design of the study, suggesting that the situation may not be as serious as has been widely reported. Robert Griffith, Editor.

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"Sow the wind and ye shall reap the whirlwind..."

And what a whirlwind it has been! The Woman's Health Initiative (WHI) is one of several prospective controlled studies of hormones utilized for supplementation in women during menopause (prospective controlled studies are planned out in advance, using both active and "placebo" medications where patients do not known which they are receiving, to help determine advantages, disadvantages, risks and benefits of a given medication).

Simply put, the WHI is a study designed to determine if the practice of placing women after menopause on "hormones" is beneficial to their long- (and short-) term cardiovascular health.

But it has become much more than that. Although serving as an educational tool and a reminder of the potential risks of combined estrogen and progestagen hormone replacement therapy in older women, it has provided ongoing fodder for the front-page fear-mongering for which the American media is so well know (see: Michael Moore's film, "Bowling for Columbine"). [See also the three Related Links below - Robert Griffith, Editor]

So, what is the WHI? What has it discovered? To whom does it apply? What is safe and what is not? What is really going on? The perhaps noninflammatory truths that are not exciting enough for media attention . . .

How the WHI study was planned

The WHI study was designed to evaluate the then-prevalent habit of physicians of placing older post-menopausal women on hormones for the express purpose of "preventing cardiovascular disease" (which is the greatest killer of post-menopausal women). The average age of women on entering the study was 63 (average +/- 15 years post-menopausal). Women enrolled in the study could not be on HRT going in; if they were, they had to stop for three months prior to the study and then be randomly assigned to receive placebo or hormones. For this reason, symptomatic peri- and post-menopausal women (hot flashes, memory challenges, mood changes, insomnia, etc.) were either not included or were self-excluded from the study.

The WHI is therefore not a study of symptomatic peri- or post-menopausal women. It's a study of older post-menopausal women, begun on HRT many years after menopause. Additionally, of the population studied, a large percentage of women were overweight, had cardiac risk factors and/or a family history of breast cancer.

Additionally, the dose of estrogen and progestagen given to these average 63-68 year-old women was the same dose as was usually given to their 40-50 something counterparts, or roughly two times the "physiologic" dose for this age group.

Let's look at the results

It's been well known for many years that estrogens have a short-term (early) harmful effect on the heart and pre-existing coronary vascular disease. The beneficial effect of estrogens is to help preserve normal vascular function after many years (over ten) of therapy by increasing the "good" cholesterol (HDL) and decreasing the "bad" cholesterol (LDL), leading to less plaque formation in arteries. It's also well known that the specific progestagen (MPA or "Provera") used in all of the WHI studies has an adverse effect on lipids, canceling out the beneficial effect of estrogens.

So: What did the investigators expect, giving short-term potent cardiac-unfriendly progestin-combined HRT to a group of women already at risk for coronary vascular disease? This says nothing about long-term benefits of estrogens (usually not seen until ten years or more of therapy in women started at, or shortly after, menopause).

One definite benefit and outcome from this part of the study was to discredit the practice of putting women, after menopause, on HRT for the singular purpose of "preventing heart disease."

What about the breast?

The biggest risk for breast cancer (other than genetics and random mutations, which are at the front of the line) is a woman's own ovaries. The hormones they secrete are far more potent that those present in any "hormone pill" you might take. Certainly an increased risk (slightly) is "bathing" your breasts in a high-level of hormones well after your own ovaries have finished their "swan song." The higher the level and the greater the time -- especially if the estrogen is combined with a progestagen (progesterone or progesterone-like synthetics, called progestins, and more especially if that progestin is "Provera") -- the greater the relative risks of breast cancer. (Even though the "relative risk" may be modestly elevated, the "actual risk" remains quite low.)

But, if estrogen alone was the culprit, how is it that the estrogen-only part of the WHI study is still ongoing? When the only estrogen tested ("Premarin") was combined with the only progestagen tested ("Provera"), a small increase in breast cancer was noted. In the same study, the same dose of estrogen in the same women for the same length of time, after almost six years, has failed to show a significant increase in relative risk of breast cancer.

Quality of Life?? Alzheimer's??

The front-page stories proclaimed ". . . no improvement in quality of life [improved hot flashes, mood, insomnia, depression, etc.], and found: ". . . cognitive function [read: Alzheimer's] worse in women on estrogen. . ."

Well, remember this: All peri- and post-menopausal women who were suffering from symptoms were excluded from the study. Of course they didn't find improvement in this factor of quality of life: They weren't studying it. Duhhh!!

Alzheimer's? It's well known from previous studies that the long-term "cognitive" benefits of estrogens, if any, accrue to women who start at the time of menopause, and continue for ten years or more. When women start on estrogens ten or more years after menopause, these cognitive improvements don't occur. The average woman in the WHI was 13-15 years postmenopausal. Hello...!

When calmer minds and many peri-menopausal experts and endocrinologists analyzed the data as described above, their thoughtful conclusions could only be found in medical journals and periodicals. If the print media chose to acknowledge these "rebuttals" at all, it was perhaps mired on page 17 somewhere. Thoughtful, non-scare analyses do not sell newspapers.

The 'Take-Home Message'?

Actually, there are four:

1. Although estrogens do confer a degree of cardiovascular protection, it is only after many years, and it is ill-advised to place women on HRT for this purpose alone.
2. The primary use of HRT is to ease the passage through menopause, either utilized primarily, or if other (non-hormonal, herbal, botanical, lifestyle) methods are inadequate. There is little evidence that short-term (probably under five years; for sure under two years) hormonal supplementation disadvantages anyone other than the women with already existing coronary vascular disease.
3. If a progestagen (bioidentical progesterone or a synthetic) is utilized along with estrogen (especially in women who still have their uterus), it should be in the lowest dose, probably given only intermittently, and should be bioidentical progesterone or norethindrone ("NET"), rather than medroxyprogesterone ("Provera").
4. If a woman decides to use estrogen therapy long-term, it should be at the lowest dose possible and with only intermittent progestagen.

That's state of the art, September 2003. Stay tuned for further developments!

You can visit Dr Goodman's website at: http://caringforwomyn.com or send him e-mail at: Mgcaringforwomen@cs.com