TCS Daily

Hormonally Challenged

By Jodi Peckich - May 24, 2006 12:00 AM

The Women's Health Initiative (WHI) prematurely ended estrogen/progesterone and estrogen-alone studies in 2002 and 2004 when adverse health risks were deemed generally to outweigh the health benefits of therapies. Although no longer considered effective to guard against heart disease, estrogen therapy remains the medical community's cornerstone therapy in treating menopausal symptoms.

So women may take comfort that the lowest-effective estrogen dose is favored only for eligible candidates to help manage menopausal symptoms. Many health researchers are confident that using such therapy for less than five years will not increase breast cancer risk. But until long-term studies confirm this supposition, the bottom line is that experts are still unsure. So, until we find out that hormone replacement therapy (HRT) doesn't in fact harm the user when taken short term, I would caution against women viewing estrogen therapy as the best measure to relieve menopausal symptoms.

This is reinforced by another finding regarding the taking of estrogen, with or without progestin. As reported Feb. 23, 2005, in the Journal of the American Medical Association (JAMA). "Effects of Estrogen with and without Progestin on Urinary Incontinence," researchers found that the active hormones in conjugated equine estrogen, whether combined with progestin or not, aggravated the frequency and amount of urinary incontinence after one year. They concluded: "Conjugated equine estrogen with or without progestin should not be prescribed for the prevention or relief of UI."

So, where are we exactly in terms of finding answers to not only relieving the symptoms of menopause but in preventing breast cancer and heart disease, not to mention the osteopenia (bone loss) that follows menopause? Has there been any silver lining to HRT research studies?

Medical experts might interpret trial results differently. Multiple approaches, such as natural versus synthetic HRT options, are fiercely debated. Yet despite the discord surrounding hormone replacement therapy, most agree that for now, collective focus remains the same: hormone resolution tenacity. In other words, we need to persist with relentless pursuit of estrogen research until we arrive at definitive answers, even if it means eventually returning to simple strategies regarding nutrition, exercise and lifestyle.

And while HRT didn't conclusively offer protection from cancer or heart disease, it has fueled the research fires in terms of finding preventive measures for breast cancer and other major diseases. But after a few surprises from recent studies, general recommendations for women remain unchanged; basically -- moderation.

Further Studies, More Surprises

The Women's Health Initiative, despite the failed expectations from the initial estrogen and progesterone trials, has attempted to salvage a glimmer of potential health benefits in other strategies for disease prevention with studies on subgroups from the original 116,000 participants.

The largest randomized clinical trial of calcium and Vitamin D supplements ever performed -- "Effect of Calcium Plus Vitamin D Supplementation on Risk of Fractures and Colorectal Cancer," New England Journal of Medicine, Feb. 16 -- has monitored more than 36,000 participants to determine the effects of calcium and vitamin D on the risks of hip fractures, bone density and colorectal cancer in postmenopausal women from 1995-2000.

Researchers found that calcium plus vitamin D supplements offered only slight benefits on bone density and reduced the risk for fractures and only in some groups. Nor were they able to prove that taking calcium and vitamin D supplements would prevent colorectal cancer.

This lack of concrete findings was as disappointing as the HRT studies. A deeper look, though, raises important questions. For instance, should the quantities of these supplements be reconsidered? And experts are revisiting basic bone-building strategies. While doctors promote the intake of vitamin D and calcium through whole foods -- and deferring to milk and yogurt ay be preferable to any prescription pad -- supplements may yet offer an acceptable second choice for those who do not achieve adequate food consumption.

Through the WHI, researchers also conducted a study of the effect of diet on health.

Nearly 49,000 WHI subjects ages 50-79 participated in the Dietary Modification Trial, which began in 1993 as the largest-scale, low-fat diet trial ever conducted. Researchers hoped to link the effects of a low-fat (20 percent of calories), and high fruit, vegetable, and grain diet on breast cancer, colorectal cancer and heart disease in postmenopausal women.

Like the vitamin D and calcium study, though, results of this study -- Low-Fat Dietary Pattern and Risk of Breast Cancer, Colorectal Cancer, and Cardiovascular Disease -- were not what women and their doctors had hoped.

As published Feb. 8, in JAMA, the study did not support that consuming a low-fat diet would prevent breast cancer in most women. The incidence of breast cancer for the lower fat diet was 0.42 percent over a mean of 8.1 years versus 0.45 percent for the regular diet, the difference of 0.03 percent might have occurred by chance 7 percent of the time and so did not meet a 95 percent confidence level. Still, researchers said that those who typically consume a high-fat diet might reduce their chances for breast cancer risk by switching to a low-fat menu.

Besides breast cancer, the study also reported no gain in fighting colorectal cancer, with an incidence rate of 0.13 percent for the low fat group versus 0.12 percent for the regular diet. The low fat diet had only a minor effect on blood cholesterol and was not found to reduce the risk of heart disease (0.63 percent incident rate vs. 0.65 percent for a regular diet), stroke (0.28 percent vs. 0.27 percent), or cardiovascular disease (0.86 percent vs. 0.88 percent).

The researchers were surprised that they were unable to establish the links they anticipated in the disease-prevention puzzle. Afterward, they wondered whether the amount of fat reduction in the study was inadequate to yield expected results, although the women who were asked to change their diet apparently found it difficult to maintain a low fat diet, as the percentage of calories consumed as fat climbed from 24 percent at the end of the first year of the study to 29 percent at its end. The researchers also considered that perhaps not enough focus was placed upon saturated fats in the diet. So investigations in both areas are currently underway.

Pending results to more in-depth investigations into these questions, though, doctors are falling back on the USDA Dietary Guidelines for Americans, as revised in 2005, which are consistent with a low-fat dietary strategy for most menopausal women.

There was one interesting finding, though, in the observational study. It found that even moderate exercise, such as walking, may provide as much benefit as more strenuous activity in protecting against breast cancer. Therefore, adequate physical exercise and weight maintenance are included in recommended strategies for prevention of breast cancer, as well as heart disease and osteoporosis. Finally, the study's results reinforce the basic need for regular breast examinations and mammograms.

Fortunately, many of the original 161,000 participants have elected to continue with WHI studies, which are planned to continue through 2010. And technological advances will allow scientists to employ gene sequencing methods to decipher what makes some women susceptible to certain diseases.

In the meantime, a number of question marks surround HRT.

Few Answers, More Questions

Perhaps the most significant outcomes from studies completed to date are the subsequent questions that have arisen, as well as the further rounds of studies that are being conducted. How might estrogen affect women who begin taking it at the onset of menopause rather than later? What are the possible effects from stopping hormone therapy? How long will it take scientists to establish true proof of a cause and effect relationship between various diets, therapies and major diseases?

The fact inquiries are continuing is of small comfort to women suffering from menopausal symptoms, who can only hope that the results -- or the passing of the next hot flash -- arrives quickly.

In the meantime, they and all consumers have a duty. The spin-off studies from the original WHI trials, translated to the personal level, do reaffirm that a moderate, common-sense approach to lifestyle -- eating, drinking and exercise -- remains our best defense against cancer, heart disease and osteoporosis. Americans generally know such a strategy results in positive health benefits - but how many are truly following it? The least they can do for themselves and their families is to try.

Jodi Peckich is the owner of beneFITs & beyond, a fitness training and wellness consulting company.


1 Comment

Why was't this article written by a prominent physician instead of a fitness businessman.

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