Doctors misunderstanding the WHI study may have cost lives

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When the federally-funded Women s Health Initiative (WHI) study was terminated prematurely, in 2002, it created a firestorm of both concern and controversy. The goal had been to determine the benefits of hormone-replacement therapy (HRT) for women entering menopause

But the results were very confusing. While some benefits were confirmed (for bone health as one example), the hoped-for improved outcomes for cardiovascular disease and breast cancer were not found. Indeed, adverse effects were detected, or so it seemed.

Subsequent re-analyses of the WHI data revealed that the immediate pessimism (with the resultant decline in HRT use of over 50 percent) was itself an over-reaction based on flawed data interpretation. Breast cancer risk was elevated only among older women who had used HRT for a decade or more, while younger women had no such effect. Women on estrogen-only HRT (also termed ERT), rather than the more common estrogen-progestin HRT combo, Prempro, had clearly improved health parameters. However, only women post-hysterectomy could receive ERT, since estrogen without progestin leads to overgrowth of uterine tissue and sometimes cancer.

A new study published online in the American Journal of Public Health analyzed WHI statistics. Based on several assumptions and estimates, the authors determined that many women who may well have benefitted from continuing on estrogen-only replacement therapy were taken off the drug due to misguided apprehension over minimal or non-existent risks among both women and, sadly, their doctors.

The new analysis was confined to women ages 50-59 who had had a hysterectomy.The authors, led by Philip M. Sarrel, MD of the Yale Medical School departments of Ob-Gyn and Psychiatry, found that ERT in younger postmenopausal women was associated with a decisive reduction in all-cause mortality, but despite this, its use in this population was low and remained so long after the facts about ERT were clarified.

The authors concluded that, across a reasonable range of assumptions, the excess mortality rate each year over the 10 year period studied attributable to misinterpretation of the WHI study was between 1,800 and 9,200 women.

These results show that clinicians should not be reluctant to prescribe estrogen for women who have undergone hysterectomy and are estrogen deficient, Holly Thacker, MD, of the Cleveland Clinic told MedPage Today. "It's not only going to improve the quality of their life but likely the longevity of their life. It's really kind of a game changer...Women and their doctors need to stop being fearful of treating estrogen deficiency."

ACSH s Dr. Gilbert Ross couldn t agree more: It is a tragedy still widely unrecognized that the prematurely-terminated WHI study led to the loss of the many benefits of HRT, and ERT, out of exaggerated fear of adverse effects. Hopefully, this new study, albeit based on many assumptions and approximations, will help reverse the momentum against indicated HRT among younger postmenopausal women.