My Take On...
Women’s Health Initiative Memory Study (WHIMS)
by PJ Hennessy July 2002
WHIMS ... Can the information from this study
be applied to women between the ages of 40-55 or to
bioidentical HRT: NO!!!
The latest papers from the Women's Health Initiative (WHI) in the spring of 2003 have generated another round of concerns, controversy, and just plain confusion. The media overreacted, sensationalized, and simply obscured the facts.
A gentle reminder: WHI was a National Institute of Health (NIH) study begun in 1992. It recruited participants whose average age was sixty-three to survey a variety of health outcomes (see Article on Women's Health Initiative). The menopause treatment studied was Prempro, at that time the most popular and widely prescribed drug in the U.S.A. Only 10% of the women were younger than age fifty-four at the time of enrollment, despite the fact that this age band is the group most likely seeking hormone treatment for menopausal symptoms. Extrapolating data from sixty year olds back to fifty year olds may be wrong-headed.
While most of you may not be interested in the fine points of statistical nuance, the declared outcomes of the researchers have been challenged by many of their colleagues. Remember, in scientific inquiry a published report is not accepted as important new knowledge until it has withstood critical comment and review by the entire discipline to which it pertains.
Here are some of the issues raised by leaders in the field of women's health. The finding of increased Alzheimer's in the treatment group was noted in the first years of the study. Biologic plausibility suggests that if your treatment is causing adverse outcomes, these outcomes grow more evident as time and treatment continued. If these events show up early, it suggests selection bias (i.e.. the deck was not properly shuffled). In addition, the WHIMS' rates of Alzheimer's noted were actually lower than those prevailing in the general population at the time, another suggestion of selection bias. The diagnostic system used to measure dementias in WHIMS is also coming under fire as an inadequate tool.
Despite the ongoing critical review of WHIMS by a jury of scientific peers, it is unfortunate that the press has grabbed the information and thrown it at us with its own prefabricated labels.
Dr. Leon Speroff, Professor at Oregon Health Sciences University and a world-renowned expert on women's endocrinology, summarizes WHIMS succinctly (if dryly), "WHI has many limitations. The individuals involved in WHI and its uncritical supporters have made a leap from conclusions regarding a select group of women over sixty to generalizations to all postmenopausal women. There are many unanswered questions. (Use of) HRT initiated early and maintained for years is not precluded by WHI."
At Women of a Certain Age, every woman prescribed HRT is evaluated yearly. Based upon her preferences and her healthy concerns, an individualized approach is created. Every successive year, we incorporate available new knowledge into her treatment plan.
(Citations OB-GYN Clinical Alert. Volume 20, Number 3. July 2003.
Wall Street Journal. October 21, 2003, Section R, pp 1-3.)
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