The following is a letter we received from colleagues digging into the details of the Women’s Health Initiative on hormone therapy for women. At MCFS, we don’t advocate for medical prescription via blog, but the following outlines some reasonable questions about the validity of the study which concluded that hormone therapy was dangerous for post menopausal women. Their arguments are solid and worth consideration:
“We have hormones on our minds [following an] open letter written by The Women’s Health Initiative Writing Group (WHI) which caused a recent stir by publishing an article in JAMA during “Breast Cancer Awareness Month” advising women about the dangers of hormone therapy. To the casual reader, their results appear to validate their long entrenched opinion that hormone therapy (HT) is risky, particularly when it comes to breast cancer. The Devil, as they say, really is in the details.
The WHI is a massive government sponsored study, examining aspects of hormone therapy in older women. It began almost twenty years ago, and somehow, continues to gamer media attention. The flaws of the study design are legion and well known. Most menopause experts point to five primary problems with the WHI, which led many of them to suggest that the results published by the WHI do not apply to the majority of menopausal women who are presently considering HT for menopausal symptoms.
#1. Wrong women
Menopause (the fmal menstrual period) occurs at an average age of 51 and is frequently accompanied with typical estrogen withdrawal symptoms such as hot flashes, night sweats, insomnia, mood matters, and meno-fog memory impairment. For unknown reasons, the WHI recruited much older women to start menopausal hormone therapy who did not have any symptoms. Many of these women had been just fine without hormones for a decade or two and then, were started on HT. These women (average age near 65) are not considered the usual candidates for initiating HT.
#2. Wrong drug
The WHI exclusively has studied only oral conjugated equine estrogen, Premarin (CEE) paired with medroxy progesterone acetate Prempro (MPA). CEE is derived from the urine of pregnant horses and contains a dozen or so different estrogens; none of which are native to human females. The MPA progestin is also considerably different from human progesterone.
#3. Wrong dose
The WHI exclusively has studies only a fixed high continuous dose of both estrogen and progestin. There was no attempt made to tailor the dose to the individual patient according to symptoms or side effects.
#4. Wrong route
The WHI exclusively has studied only orally consumed hormone pills and not transdermal or transvaginal HT.
#5. Wrong questions
The WHI has spent, seriously, about $1 billion (with a capital B) answering a question that no one cares about. Most women over age 6S are not started on HT out of the blue; a 45 to 50 year-old woman with screaming hot-dreads is another matter.
Many experts have criticized the recent WHI JAMA article because their data did not reach statistical
Significance. This means that their so-called conclusions are just as likely to represent a random accident of chance. It’s a little like if you go to the grocery store, and there is a green Ford in the parking lot, and the lettuce is on sale, 4 for a dollar. You pronounce that the green car gives rise to cheap lettuce. In reality, it is just a chance happening and does not represent any meaningful truth. It is also interesting to understand how off-kilter this WHI study is by looking at their results in regard to how many women in their study died from breast cancer. The recent WHI JAMA study reported that the death rate from breast cancer was too high for women on oral estrogen plus progestin, Prempro, and the figure was 2.6 deaths per 10,000 women per year. Astonishingly, they make no mention of the fact that for women in this age group (65-74), the published death rate due to breast cancer is about 8 per 10,000 women per year. In other words, the women in this WHI study on hormones had about 1/3 of the death rate from breast cancer than the general population. Where are the headlines stating that?
The fanfare regarding these findings is misplaced. The insignificant non-finding of one (1!) extra breast cancer death per 10,000 women per year for women on oral conjugated estrogen with progestin (prempro) therapy is quibbling at best, and borders on deception. In fact, the World Health Organization considers this range of effect as “extremely rare”.
Here is what we presently know about Hormone Therapy for menopause. Estrogen has unmatched safety and effectiveness in relieving menopausal symptoms, vaginal atrophy, and prevents osteoporosis. There is a window of opportunity when initiating HT is advantageous, but waiting to start until after age 70 poses risks.
Bodyldentical estrogen is the exact duplicate of the estrogen made by healthy women during their reproductive years and is much preferred over non-human hormones such as those studied by the WHI. BodyIdentical hormone (FDA approved) should be administered trans-dermally as a patch, spray, gel, cream or trans-vaginally by a ring. The dose of BodyIdentical estrogen should be tailored to the lowest effective dose to manage the menopause symptoms. Bodyldentical oral progesterone (Prometrium) should be paired with transdermal estrogen if a woman still has her uterus.
The link between estrogen and breast cancer is complex and not understandable by any single study. Of course, estrogen is intimately associated with breast cancer because estrogen makes a person a woman, and women develop breasts. In the absence of breasts (also referred to as a male) breast cancer is rare. With that in mind, however, consider the fact that young women make huge amounts ofestrogen, but less than 2% of women under age 50 develop breast cancer. On the other hand, more than 10% of women over age 80 develop breast cancer, and they have not had any estrogen for three decades. It is a curious relationship indeed.
Many hormone experts today believe that the type of progesterone used for menopausal hormone therapy is more important in the development of breast cancer than the type ofestrogen. The progestin used in the WHI study probably has deleterious effects, and the BodyIdentical progesterone does not. The WHO, in spite of alI the press reports, has actually proven that for women who have had a hysterectomy and take estrogen alone for menopausal hormone therapy, the incidence of breast cancer is significantly less than the incidence of breast cancer for women who choose not to take menopausal hormone therapy.
Breast cancer results in 40,000 deaths in the US each year. However, women are 15 times more likely to die from something other than breast cancer. For instance, cardiovascular disease alone is 10 times more likely to kill an American woman than breast cancer. It has been conclusively shown that menopausal hormone therapy significantly reduces the incidence of cardiovascular disease, heart attacks and strokes, diabetes, osteoporosis, depression, and dementia. In fact, hormone therapy reduces the risk of dying from anything by 40%, compared to women who do not take hormones for menopause.
Many underestimate the relationship between breast cancer and lifestyle. There is now unequivocal evidence that a real food diet with a preponderance of calories coming from vegetables, whole grain, and fruit coupled with higher levels of physical activity (also known as exercise) reduces the incidence of breast cancer orders of magnitude more than the questionable increases seen with oral non-human hormone therapy. And one more thing, those who advocate for reduced mammogram screening have only economic interests at heart and are not particularly concerned with your personal health. We recommend, as does the American Cancer Society, mammography every year after age forty, or sooner if there are certain risk factors.
No one knows why the WHI is so famously anti-hormone therapy for women, but they certainly ~e persistent. They continue to invent quirky mathematical models to discredit HT, as though they could construct an alternate universe where women’s health and wellbeing would be uncoupled from women’s principle hormone: estrogen. Women are encouraged to examine the whole pie, not just the little slices doled out by the media reporting the latest WHI study. For other good sources of information check The North American Menopause Society (NAMS) or, The American Cancer Society.
We would love to hear your thoughts and questions. Leave us a comment.”
David C. Miller, MD, MA, DABPM, FIPP, ABIPP, NCMP
Lovera Wolf Miller, MD, FACOG, NCMP
health 4 her
Michigan City, IN USA