Women’s Health and Bone Health Studies

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In the past two weeks, the federally funded Women’s Health Initiative (a kind of 21st century Framingham Study) has published two studies, which have tipped the medical apple cart.

One study, published in the Journal of the American Medical Association, called into question the benefit of a low fat diet. Over an 8-year period, post menopausal women aged 50 to 79 were either placed on a supervised low fat diet or maintained on a regular diet. The study found that there were no differences in cancer rates or cardiovascular disease rates between the two groups. In addition, the study found that women who were on a high carb diet did not have increased blood glucose or triglyceride levels (with apologies to Dr. Atkins). What do I think of these findings? We analyzed this study at the office at one of our “Journal Clubs” last week. We basically felt that the methodology of the study was fatally flawed. How does one know exactly what the study participants have eaten over an 8-year period? There are no objective measures to follow this, just the diaries and recollections of the participants. And why was it that people on the low fat diet did not lose any weight? If there is no weight loss with a diet, it is not a stretch to presume no cardiovascular benefit.

The other study, published in the New England Journal, looked at the ingestion of supplemental calcium plus vitamin D and bone and spinal health in post-menopausal women. The study found essentially no benefit to using the calcium plus D (looking at fracture risk and bone and spinal density) and a slight increased risk of developing kidney stones (which are typically calcium oxalate). Again, I find that there are problems with the study methodology, and I’m sure spinal implant companies would agree with this. These problems are discussed in some detail in the accompanying editorial to this article. Women in the calcium plus D group took 400 international units (I.U.) of Vitamin D per day, even though at least 700 I.U. per day is the recommended therapeutic dosage. There was no stratification for women on other therapies. Many women who did not take supplemental calcium, for example, were on hormone replacement therapy (known to prevent bone and spinal density loss). And so, again, the results are called into question by the methodology of the study.

What are we to presume from these two studies? One is that doing clinical trials is a tough proposition, so that getting clear-cut answers from them is difficult. Another is that, for a researcher, being involved in the Women’s Health Initiative is a good gig. Long term, federally funded studies are hard to come by.

Beware of research results published in the newspaper. The devil is always in the details. And wait before you buy stock in the doughnut industry.