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A New Paradigm in Medicine and Health Care: 1. Current Paradigm (d)
In Part 1(c), I chose as a third example of the current paradigm of population medicine, the case of mammography. I argued that:
Since the guidelines for screening mammography advocated by the several professional associations or/and governmental organizations are conflicting and even confusing, this screening should be conducted on an individual basis and only in case of significant risk?
Since the radiation sensitivity of the breast in women under age 35 is possibly greater than in older women, it would be generally imperative that these women be screened only if there is a significant risk of cancer (such as, BrCa positive, very positive family history, palpable mass), and even in these circumstances the screening should employ ultrasound or magnetic resonance for imaging.
Screening of women aged between 40 and 49 should not be routine but based on individual's risk factors and values (because the benefits of screenings do not outweigh the risks).
Beyond age 50, screening should not be conducted systematically but only infrequently at appropriate time intervals to be defined.
Based on the important Cochrane Collaboration and the Nordic Cochrane Collection, routine screening should be discouraged for healthy women of any age as the risks might outweigh the benefits.
Whereas much more could be said about the mammography test, I would now like to proceed to my fourth and last example of hormone replacement therapy.
Fourth Example: Hormone Replacement Treatment (or Therapy) (HRT)
Hormone replacement therapy refers to any form of hormone therapy wherein the patient, in the course of medical treatment, receives hormones, either to supplement a lack of naturally occurring hormones, or to substitute other hormones for naturally occurring hormones. We are here interested solely in hormone replacement therapy for menopausal women.
The idea is that treatment may prevent the discomfort caused by diminished circulating estrogen and progesterone hormones, or in the case of the surgically or prematurely menopausal, that it may prolong life and may reduce the incidence of dementia. It involves the use of one or more of a group of medications designed to artificially boost hormone levels. The main types of hormones involved are estrogens, progesterone or progestins, and sometimes testosterone. It is often referred to as "treatment" rather than therapy.
Many studies on the effects of HRT have been conducted on rats. Overall, the results of these studies are non-conclusive and more research in this area is needed. Nonetheless, some important results can be gathered: (a) Differing brain regions may respond in a variety of ways to HRT; (b) Timing of the therapy is integral to the chances of success; and (c) How the hormones are administered, either chronically or cyclically, may make an important difference in their effectiveness.
As recently as 2005, women have had a positive and overly optimistic attitude towards HRT. Currently, however, most women do not find HRT to be an effective solution: It is initially helpful but if used for a long period of time it loses its effectiveness, and there are times when it is not only ineffective but actually detrimental to people.
In the case of menopausal women, HRT has had the following adverse effects: impaired hearing including decrease in the functionality of many regions of the ear, reduction of the effectiveness in parts of the central nervous system used for hearing, and increased chance for cardiovascular disease (particularly in the case of women caregivers who experience more acute stress in their lives). However, HRT can have beneficial effects: positive effects on the prefrontal cortex by boosting the working memory, no additional weight gain compared to women who do not use HRT, positive effects in their sex life (mainly increasing their sex drive and sexual sensitivity) that can dissipate after receiving HRT for extended periods of time ... but the effects are inconsistent across women.
For decades, Hormone Replacement Therapy (HRT) was widely recommended to women to reduce heart disease. However, the Women’s Health Initiative (WHI) trial (over 16,000 post-menopausal women) compared the combination (estrogen + progestin) to placebo. The findings included significant increases in breast cancer, heart disease and heart attacks, strokes, and dangerous blood clots. These findings far over-rode the alleged benefit of less colon cancer and fewer hip fractures. The results of the WHI trial were so negative that it was stopped prematurely, at 5.6 years (instead of the planned 15 years) of follow-up. New results released in 2011 continue to engender confusion, suggesting disparate outcomes with hormone replacement as a function of what age the treatment was initiated.
Nonetheless, after a slowing period following the announcement of the trial’s negative results, the practice continues under the guise (true perhaps for some women) that HRT (estrogen and/or progestin) palliates the unpleasant “hot flashes” post-menopausal women experience. But, this latter “benefit”, even if true, is not the premise on which HRT was advocated and sold.
Of last note, a recent report in the Archives of Internal Medicine revealed that “post-menopausal women who were treated with statin drugs to lower their cholesterol (see article 1(a) in this series) had a nearly 48% increased risk of developing diabetes compared to those who were not given the drug. This is even more critical when we consider that becoming diabetic doubles the risk for Alzheimer's disease. The combination (HRT + statins) is of serious concern..
In summary: Whereas initially helpful, used for a long period of time, HRT loses its effectiveness, and there are times when it is not only ineffective but actually detrimental. In the case of menopausal women, HRT has multiple adverse effects (impaired hearing including decrease in the functionality of many regions of the ear, reduction of the effectiveness in parts of the central nervous system used for hearing, and increased chance for cardiovascular disease particularly in the case of highly stressed women). However, it can also have beneficial effects (boosting the working memory, no additional weight gain, positive effects in the sex life) that unfortunately can dissipate after receiving HRT for extended periods of time. Whereas significant increases in breast cancer, heart disease and heart attacks, strokes, and dangerous blood clots were found in a large and important clinical trial, HRT was discontinued for a time period but is witnessing a resurgence for alleged other benefits (palliation of hot flashes). Again, even when the surrogate end point is no longer tenable, another surrogate end point is found to justify the continued of the therapy (a common marketing ploy).
What then is the key to the change in this population medicine paradigm? It resides in the 6 rights: “right” doctor, “right” screen test, “right” patient, “right” drug, “right dose”, and “right” cost. We will next consider how this could be tackled and hopefully implemented.
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