Excerpts from ASCO 2004

Sunday featured a presentation on “Implications of the Women’s Health Initiative”.

This was a series of discussions on what we now know about hormone replacement therapy. Dr. R. Chenoweth pointed out that as a result of recent trials, 33 million less prescriptions were written for hormones. Negative results included more congestive heart disease, more strokes, and pulmonary emboli.

One thing of interest was a statement that the trials did not see more cases of invasive lobular. This had been discussed in the past but is not proving out. Interestingly the risk of breast cancer is decreased almost 40% in the first year of hormone use, down to a 23% reduction in risk in the second year and increased risk from then on. I asked if it would be a useful strategy to take HRT for one year, stop for a while (undefined) and then take it for another year? Of course we do not know the answer.

The only strong benefit shown was a reduction in the number of colorectal cancers but the bad news was that the cases that did show up were more likely to have positive nodes and be metastatic (shades of finasteride – more on that later).

Overall statement “No indication of chronic disease risk reduction”. There has been so much discussion as to why the whole country jumped on the hormone replacement wagon, and it is a complex discussion. There were observational studies that seemed to indicate a benefit. Certainly too much was made of the idea without any clinical trials.

Jennifer Hays from Baylor College of Medicine discussed the Women’s Health Initiative (WHI) study. She told the audience that the participants were informed in April, 2000, of the increased risk of cardiovascular disease during first two years of use. In November, 2001, the women were told that the risk does not disappear after four years and in July, 2002 the trial was stopped. (JAMA, 2000 288)

An increase in risk of stroke was shown in the trials, 31% with estrogen/progesterone and 39% with estrogen alone. The only unequivocal benefit was a reduction in hip fractures (after almost seven years). The risk of dementia almost doubled in the estrogen/progesterone group, particularly high among women over age 65.

Kathy Pritchard, MD (Toronto) spoke about the HABITS and Stockholm trials (from Sweden), which followed 1300 women for five years. Women with a uterus were given estrogen plus progesterone and those without, just estrogen. There was more local recurrence of breast cancer, more contralateral and more distant mets on the HRT arm versus placebo. There were more serious adverse effects of all kinds with HRT.

Dr. Pritchard mentioned that diet and exercise was useful for prevention of heart disease, osteoporosis, and colon cancer.

I asked whether we had data on long-term developments of breast or colon cancer or heart disease. The women in the WHI will be followed for five more years so there will be more data forthcoming.

One interesting result of stopping the US trial was that all the women stopped on the same day (per a letter of instruction). Thus they are an excellent cohort for follow up.

All the women were scheduled for mammograms at the same time as well. Dr. Runowicz suggested that some women would continue to take estrogen given by their own personal physicians, so the group might have some confounding factors.

There was a question on vaginal estrogen – ‘estring’. Dr. Pritchard originally thought that it could be used sparingly but some evidence now suggests it may raise lipid profiles. There were two papers with opposite results. Dr. Chenoweth stated women should be told there is uncertainty. Dr. Runowicz suggested that ‘vagifem’ showed higher absorption levels and Dr. Hays said topical estrogens might have less risk.

At the end, there was some discussion of sexual satisfaction. Dr. Hays said there would be some data from the analysis of the estrogen and progesterone trial. Dr. Pritchard said the data was limited because the women were not necessarily highly symptomatic. 75% of the women on estrogen/progesterone said their hot flashes improved, while 52% felt that way on placebo.

And a final comment said are some studies looking at whether hormone replacement helped skin look better. One of the speakers said that effect might be seen mostly on the back or other areas, rather than the face.

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