What's A (Peri) Menopausal Woman to Do?

We at Camelback Women's Health have been concerned about the recent National Institute of Health's decision to discontinue the combination Hormone Replacement Therapy arm of the Women's Health Initiative study. We have had an opportunity to review in some detail the actual research protocols and results and would like to place those results in context for our patients.

As you may have heard in the press, the NIH made a decision to discontinue the combination (estrogen + progesterone) hormone replacement arm in the study because of a slight increased risk of breast cancer in the group receiving continuous combined HRT compared to placebo over a 5-year period. The study also reported no proven benefit in the reduction of heart attacks. The full data in that study however is not clearly presented in most of the news reports.

It is first important to note that the study patients were all older, with the average age of the study population being 63 at the beginning of the study and 68 at the conclusion of the study. There was a mild increase in the rate of heart attacks and strokes in the first year of the study, which is consistent with our general understanding of certain sensitive individuals when initially exposed to estrogen. 

Since most women who begin menopause have been started on HRT around age 50-52, its still very unclear whether heart disease risk is reduced or whether there are fewer adverse events or more benefit in younger patients that have less established coronary artery disease. In essence, starting HRT this late in the study may have been too late for these patients to reverse ongoing heart or vascular disease. There is still evidence that HRT has a beneficial effect on lipid profiles. 

As mentioned, the NIH report showed an increase of 8 cases in 10,000 women per year in breast cancer, while also reporting 6 fewer colon cancer in 10,000 women per year. There was no added risk in those patients taking estrogen alone. While not clear, this may implicate the progesterone in Prempro as the cause for the added risk. 

In a study in the New England Journal just a week before the NIH report, there was no evidence of an increase risk of breast cancer in those women using birth control pills long term. This finding has been shown over and over in numerous studies. Birth control pills use a different estrogen and a different form of progesterone and in 3-5 times the strength of HRT. In fact, in this recent report, the relative risk was 0.9, or less than those patients that did not take birth control. In theory, lower doses of these same pills should also carry no added risk. HRT is now available in low dose forms of the birth control preparations.

While avoiding drugs that may have added cancer risk is important, the reduced risk of colon cancer should keep the cancer discussion in context, since colon cancers can have a higher risk of mortality than breast cancers in those patients on HRT. The overall risks (or benefits) for cancer while using HRT are very low. Deaths by all causes in the NIH study were the same in the treatment group and the placebo group.

Of importance, the NIH study showed no increased risk of breast cancer among those women taking estrogen alone. The NIH made a very specific point of noting that they were continuing the estrogen arm of their study for women who have had hysterectomies and therefore did not require progestin. This should be quite reassuring for our patients who are taking estrogen alone.

The NIH study did show a reduction in hip fractures, consistent with the known benefits that HRT has in protecting from osteoporosis.

The NIH study did not address the other reported benefits of HRT. One of the more compelling reasons to offer HRT is the beneficial effect that estrogen may have on brain function. Numerous reports are now showing reductions in the rate of Alzheimer's disease and short-term memory loss in patients taking estrogen. Hot flashes, once considered a nuisance but benign, may in fact be evidence for or even a cause of cognition and memory loss.

In addition, most women report less irritability, better skin and joint function and an overall better sense of well being with the use of HRT. These benefits, while not quantifiable, should be taken into consideration when making an informed decision on whether to use or discontinue use of HRT.

Nonetheless, options available in light of the NIH study include:

• For those patients who feel well or better on HRT, staying on the medication is still good advice, provided that an annual mammogram is done. 

• For those patients without any risks for heart disease or osteoporosis and without other symptoms such as hot flashes or mood disturbances, it may be reasonable to stop HRT. 

• Patients with signs of osteoporosis can use alternative medications specific for this problem such as Actonel or Fosamax, along with calcium supplementation and added exercise. 

• For patients worried about heart disease, specific risk factors need to be addressed, including cholesterol levels, smoking, exercise and diet. HRT may still have benefits.

• For those patients concerned about breast cancer specifically, an alternative for osteoporosis prevention with no known added breast cancer risk is Evista. We have begun offering patients on Prempro to switch to alternative HRTs that have birth control estrogens/progestins, given their established safety profile in younger women.

Companies that promote natural therapies are stepping up their marketing in the wake of the NIH press. While these medications can alleviate symptoms, their safety has never been studied as it relates to cancer or heart disease. The therapies are also very likely safe. Natural hormones are simply either plant based estrogens or progesterones and therefore may carry the very same risks reported in the NIH study. Be reassured that most HRTs prescribed by physicians, except Prempro, are plant based.

In conclusion, we are advising our present patients and any new patients with menopausal complaints to weigh all the risks and benefits as they relate to their specific risks and medical circumstances. This is consistent with advice being given by national experts. Patients using HRT should be reassured that any risks associated with HRT are still very low and we feel that there is still considerable benefits for many patients. We would encourage all our patients to discuss HRT and your specific circumstances at your next visit.

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