About the age of 50, women go through menopause, which is associated with the cessation of ovulation and menstrual cycling, and a decline in estrogen and progesterone levels. The conclusion that women needed to ?replace? their female hormones after menopause has a long history driven by the idea that a decline in hormones leads to unnatural and unwanted effects on libido, memory, and cardiovascular health, none of which had any basis in fact.
It all started with a book written 40 years ago called Feminine Forever, by Dr. Robert A. Wilson. It was a national bestseller when it was published. Wilson, a British-born gynecologist who practiced in Brooklyn, New York, and later, on Park Avenue in Manhattan, persuaded the public that, ?Many physicians simply refuse to recognize menopause for what it is ? a serious, painful and often crippling disease.?
His solution was to give women over the age of 40, hormone-replacement therapy (HRT). The FDA had actually approved HRT back in 1942 to treat the hot flashes, difficulty sleeping, mood swings and other symptoms that can accompany menopause. Wilson argued that HRT was a near miracle remedy that could stem a woman?s aging process and improve their sex lives. By defining a natural process as a disease he managed to help the pharmaceutical industry push HRT on healthy woman as a drug they needed to take every day for the rest of their lives. For the pharmaceutical industry this notion created a dream situation of finding a huge segment of the normal population that they could sell their pills to. No matter that there was no good research to support their claims. This idea was very popular for many years, before real controlled trials showed that HRT was very bad, and had caused tens of thousands of deaths in women, as well as other problems.
Hormone replacement therapy (HRT) involves replacing the body?s natural hormones after normal or surgically induced menopause. Common brand name examples of HRT include premarin (estrogen from a horse), provera (progesterone) and prempro (combination). About 20% of women will develop uncomfortable, and sometimes unbearable, hot flashes during the peri-menopausal period. Some women develop other or additional symptoms, such as problems with rational thinking or depression. These symptoms can be treated successfully with HRT. Other hormones, like testosterone, can be used for purposes such as treating low libido in women.
Although HRT has a role in treating hot flashes for a time-limited period, or occasionally depression or insomnia, it has been marketed for a much larger number of women. For much of the history of HRT, it was believed that HRT prevented heart disease, stroke, and osteoporosis, and that it improved well being, sexuality, memory, and mood. However, there was some early evidence from the Nurses? Health Study published in 1995 that showed a 32% increase in breast cancer with HRT. Nevertheless a great deal of marketing was done on behalf of HRT and pharmaceutical companies made billions of dollars by arguing that all post-menopausal women needed to take it for their health. There was supposedly the added benefit that HRT would make you look better and improve your sex life.
However, none of this held up to the test of time. The original evidence that HRT prevented heart attacks was based on what are called observational studies. Women who chose to take HRT were compared to those who didn?t, and were found to have fewer heart attacks. It turned out that women who took HRT also were more concerned about their health. They did other things, like exercise and diet that were beneficial for heart attack. The HRT didn?t do anything. Yet eight years went by from 1995-2003 with major marketing to women and billions of dollars in sales. The pharmaceutical companies had hit on the mother load of all markets. Not just patients with a disease, but all women over age 50.
The observational study design, however, is inherently flawed. It is easy to have some systematic factor creep in that will skew the results. The only way to answer a question like does HRT prevent heart attacks, is to do a controlled study where women get either HRT or a sugar pill, they don?t get to choose which one, and they (and their doctors) don?t know what they are on. At the end of five years, you compare outcomes (i.e. heart attacks) between the two groups. It took so long to do such studies because it was argued that it would be unethical to give a sugar pill to women when HRT had such obvious benefits.
More recently controlled trials have been performed. The Women?s Health Initiative (WHI) involved the random assignment of 16,608 post-menopausal women to estrogen and progestin (equine estrogen and medroxy-progesterone, or Prempro) versus a placebo from 1993 to 1998. Women on Prempro had a statistically significant 24% increase in risk of heart attack or cardiac death. HRT increased the risk of breast cancer by 24%,65 and doubled the risk of pulmonary embolus (blood clot in the lung).66 There was about a 50% increase in ovarian cancer that was not statistically significant, mainly because ovarian cancer is much less common than breast cancer, with no increase in uterine cancer. HRT had no effect on cancer all cancers combined, and reduced the risk of osteoporotic fracture.66 HRT increased the risk of stroke by 31%.
The Heart and Estrogen/Progestin Replacement Study (HERS) involved randomized blinded treatment of 2768 postmenopausal women with a history of heart disease for 4 years with estrogen plus progestin (conjugated estrogens and medroxyprogesterone, or Prempro) or placebo with 2 years of follow up. There was no protective effect of HRT against recurrence of heart disease. There was a 10% increase in mortality with HRT, related in part to a doubling of the risk of potentially lethal blood clots, and a 48% increased risk of gallbladder disease requiring surgery. HERS also showed a pattern of increased cancer risk that was not statistically significant.
Other studies of estrogen replacement have shown increased rates of uterine and ovarian cancer. HRT doubles the risk of blood clots that can lead to deadly pulmonary emboli (blood clots that travel to the lung and have up to a 50% mortality rate). HRT also increases the risk of gall bladder disease and of getting your gall bladder removed by 60%. For every one hundred women treated with HRT in WHI, one woman developed a serious adverse event directly related to the HRT.
Another study showed that HRT actually accelerated the progression of thickening of the coronary arteries, and doubled this risk of dying of heart disease. A recent metaanalysis showed a 29% increase in risk of stroke. Based on these findings, there is no role for HRT in disease prevention.
HRT had no effect on sexual function when looked at in the proper way with controlled trials. When I say no effect, I don?t mean some effect that was not statistically significant, I mean zero effect. There was also no effect on mood. After one year women on HRT reported miniscule improvements in sleep and pain, but those were back to zero after three years.
So what was all the fuss about how HRT helped women?s sex lives? It was all a placebo effect. You could give a woman HRT and she would have a 25% improvement in her sex life. But you could give a woman a sugar pill and it would have the same effect, and wouldn?t give her a heart attack.
There has been a lot of interest in whether or not memory and cognition are affected by HRT. Men and women have a decline in memory that normally occurs with aging. Estrogen affects brain areas involved in memory like the hippocampus, which has led to the idea that the decline in estrogen after menopause is associated with a decline in memory function. Based on observational studies, it was originally believed that HRT prevented the development of Alzheimer?s Disease and other dementias, and improved memory function or delayed the normal decline of memory with aging in women without dementia. However, ?smart? women at the time were doing things that they thought were good for their health, like taking HRT, which could lead to obvious biases in these types of studies.
In fact, although HRT was originally hypothesized to prevent dementia, when carefully assessed it was found to actually double the risk of dementia. HRT also resulted in a small, but not clinically significant, reduction in cognition in one study.
The largest study, the Women?s Health Initiative, that did not find an effect on cognition, used a measure called the Mini Mental Status Exam, which asks questions like ?what year is it?? or ?name this object?. You can see that this is a fairly gross measure of memory and cognition, and might not pick up subtle changes. Based on this, some have argued that estrogen benefits more specific memory processes. However, combining results from women treated with estrogen alone and estrogen plus progesterone showed that hormones also caused a worsening of cognition.
A number of studies have looked at more subtle and specific memory functions. Studies in women without depression or dementia found no change in a variety of specific memory tests, including ability to learn word pairs, find words, remember a paragraph, or connect numbered dots. Most importantly, the studies that used random assignment to HRT or placebo for postmenopausal women, eliminating the kind of self-selection of educated women to take HRT which can influence results of these studies, showed no effect of HRT on memory.
In terms of benefits, HRT does reduce the loss of bone mineral density that occurs with normal aging, and reduces the risk of osteoporotic fracture. There is also minimal evidence that it improves sleep. However, these benefits are far outweighed by the risks of HRT. Women who have discomfort from hot flashes benefit from HRT. HRT leads to an 80% reduction in symptoms with an associated improvement in quality of life. HRT also improves memory and cognition in women with highly symptomatic hot flashes. If used for a short time, there is a good chance that the hot flashes will come back when HRT is stopped.
The major studies comparing HRT to placebo did not include women with mental disorders. HRT has been shown to be better than a placebo in the treatment of depression in women who develop depression around the time of menopause. Stressed post-menopausal women who were caring for a spouse with depression reported lower hostility when compared to placebo. Replacement of estrogen and testosterone in women who had their uterus and ovaries removed also resulted in an improvement in mood.
Learn more about alternative treatments for menopausal symptoms and hidden risks of prescription medications in Before You Take That Pill: Why the Drug Industry May be Bad for Your Health: Risks and Side Effects You Won?t Find on the Label of Commonly Prescribed Drugs, Vitamins and Supplements, by researcher and physician J. Douglas Bremner, MD.
http://www.beforeyoutakethatpill.com
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