Imagine trying to change the course of an ocean liner, without a compass, in the midst of a raging storm.
In the four months since the Women’s Health Initiative (WHI) abruptly discontinued its multiyear hormone replacement therapy (HRT) study – researchers, doctors and the women they serve have been trying to figure out where they are, and, more importantly, where to go next.
Last week, the National Institutes of Health (NIH) held a two-day conference in Bethesda, MD, to assess the status of ongoing studies in the HRT field. In the end there was consensus on a few details, but comments that came from various participants made it obvious that we’ve entered a new era in estrogen therapy – an era that some describe as being in “disarray.” But I don’t agree. I think to many it simply seems like disarray compared to the days when estrogen therapy was almost an automatic prescription for menopausal women – regarded as a safe preventive for heart disease and osteoporosis, and a carefree miracle cure-all for a host of symptoms associated with menopause.
Those days are gone.
If you’d like to draw the attention of the national media, launch an expensive 8-year federal study involving almost 17,000 subjects, and then shut it down after 5 years because the drug you’re studying may cause heart attacks and cancer.
It’s no wonder that the July 9, 2002, announcement that WHI was discontinuing its HRT research drew a storm of media attention. As I told you in an e-Alert on 7/9 (“All the News That’s Fit to Print – Plus the Truth!”), this large study was designed to help understand the safety and efficacy of Prempro (a combination of Premarin estrogen and progestin). Specifically, the study was intended to assess the claim that this estrogen combination drug, taken over a period of years, might help prevent chronic health problems such as cardiovascular disease, osteoporosis, breast cancer, and colon cancer. In May, an NIH committee decided to stop the study when it became clear that the women using the hormone were experiencing a greater incidence of breast cancer and heart attacks than the placebo group.
Then, in August, the National Cancer Institute reported that post-menopausal women who take estrogen for 10 or more years may have a full 60% higher risk of developing ovarian cancer than women who never use HRT. This research was gleaned from records gathered over a 19-year period from more than 44,000 women who participated in a screening program called the Breast Cancer Detection Demonstration Project.
The negative impact made by these studies is still strongly felt by doctors and women alike who are now unsure of which way to turn to reduce the symptoms of menopause.
According to Dr. Ruth Kirschstein, NIH Deputy Director, a new acronym is now being used for HRT. What has until recently been called hormone replacement therapy, will now be referred to as menopausal hormone therapy – identified by the simple acronym “HT.” I suppose that’s one way to begin removing negative stigmas: if women don’t trust HRT, maybe they’ll trust HT. And don’t misunderstand: just because NIH stopped the WHI study, that doesn’t mean that it’s advising women to stop using hormone (replacement) therapy.
Although some of the 500 or so doctors and researchers at the NIH conference acknowledged the possibility that short-term use of HRT may have risks, by and large the consensus overall was that HRT use for less than 5-years is probably safe. This, in spite of the fact that the WHI trial showed that some women who took HRT for only two years had a higher risk of breast cancer and heart attack than the placebo group. (As I mentioned above: it’s a new era – no easy answers.)
The big change in thinking is the shift against the idea of using HRT to prevent long-term chronic diseases associated with aging. It’s as if HRT has been demoted – its primary usefulness now only applied to the symptoms of menopause, such as hot flashes. This, however, doesn’t take into account one ongoing HRT study from the National Institute on Aging (NIA). This study is examining the effects of HRT on a group of 900 women over the age of 65 who are all considered at high risk to develop Alzheimer’s disease. A committee that oversees the study has decided that it’s so important to find out if HRT can limit the disease that the study should be continued. Meanwhile, three previous NIA studies have already concluded that estrogen does not slow the course of Alzheimer’s for patients who have already developed the disease.
Most of the reports regarding the abrupt halt of the WHI study last July state that the study was examining the effects of a combination of estrogen and Progestin. This makes estrogen sound generic – as if there were only one choice. In fact, the study used Premarin – a pharmaceutical that combines a synthetic version of the natural hormone progesterone with the urine of pregnant horses (Premarin = PREgnant MAre’s urINe). And as you might suspect, there are other, more natural ways to go in treating the concerns of menopause.
Very often, a condition called “estrogen dominance” is the trigger for menopausal side effects. Estrogen dominance is nothing more than the imbalance between two hormones: estrogen and progesterone. Many women report remarkable results in managing menopause problems with natural progesterone treatments. So why hasn’t this particular hormone therapy been addressed by NIH? Could it be because progesterone is available without a doctor’s prescription? In other words: progesterone does not have a powerful lobby or the massive funding that a prescription drug like Premarin has.
Last July, after the WHI study was shut down, I received an e-mail from an HSI member named Dr. V. In an e-Alert I sent you on 7/15/02 (“Where the Yellow Went”) I included these comments from Dr. V.’s e-mail about the drugs used in the WHI trial:
“It is a well known fact in the professional world that the HRT derivatives being used were synthetics. Unfortunately the average individual does not understand the details and, in my opinion, the media is as responsible for confusion as anyone by leaving the educational component out of the report. Progestin is a patented drug form of the real deal namely progesterone.
“I wanted to add one more piece of information. Please do not forget those wonderful [omega-3] essential fatty acids for hormonal health. I cannot tell you the degree of satisfaction I achieve just adding essential fatty acids, equivalent of 2-3 tbsp. daily, and digestive enzymes, preferably broad spectrum and above average potency, along with watching your starch or complex carb intake. Don’t forget the importance also of eating fermented foods such as organic yogurt, no fat free stuff, sauerkraut, and apple cider vinegar. The health of your intestinal flora will also keep healthy estrogens recirculating thereby helping to control pre-ms and post-ms symptoms. We should always choose natural over synthetic hormones.”
From Dr. V.’s mouth, to NIH’s ear.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
