It's a rare thing to see a major, multi-year study involving thousands of subjects abruptly halted. But that's what happened today when the Women's Health Initiative (WHI) announced that its study of hormone replacement therapy was simply too dangerous to continue.
But wait - if you're currently undergoing prescription HRT, don't run to your medicine cabinet and throw it out. Not yet, anyway.
First let's go over the details, and then I'll walk you through the alternatives (alternatives that you surely won't hear discussed on this evening's news broadcasts).
To begin with, the decision to halt the study was reached ONLY as a result of the combined use of estrogen plus progestin. That narrows the group at risk to no less than 6 million women who are currently using estrogen to replace hormones lost at menopause, and adding progestin as a precautionary medication to prevent estrogen from causing cancer of the uterus.
The study was stopped because, after reviewing the most recent round of data, the WHI Data and Safety Monitoring Board recommended that the overall health risks exceeded the benefits. Specifically they found an unacceptable level of invasive breast cancer among the subjects in the study who were receiving both estrogen and progestin.
But that's not all - not by a long shot. The board also concluded that these subjects were at additional, but somewhat less, risk of heart attack and stroke. So please, if you're one of the 6 million currently using these two drugs together, call your doctor immediately to discuss the details of this report.
After hearing the report, I have to ask the question: Why wasn't the trial concluded sooner? Why didn't the participants get a warning against using these two drugs together weeks ago, in early June?
After all, it was on May 31, 2002, that the WHI Data and Safety Monitoring Board recommended stopping the trial. I understand that a report of this nature is complex and can't be thrown together overnight (especially where there's a bureaucracy involved). But with the health of so many women in the balance it would seem that a delay between the recommendation and the announcement was much too long: more than 5 weeks. To me, that's simply unacceptable. The researchers knew that the women in the study were at risk. Surely they had a responsibility to instruct them immediately to discontinue their medication. They owed them that. It's important to note that there is no evidence from this study that taking estrogen alone will produce any of the above-mentioned side effects. In fact, WHI is currently conducting an additional clinical trial to study the effects of estrogen alone on 11,000 women.
But over the past few months, I've written a number of e-Alerts about HRT ("The Latest Con" 6/5/02, "Déjà vu All Over Again" 4/11/02 to name just two), and the common thread is this: the decision to use HRT is a personal choice, and you have to be fully informed to make it.
We've now seen additional evidence that there are risks specifically associated with combination therapy. Post-menopausal women - especially those who have not had hysterectomies - can seek alternatives to estrogen therapy. For instance, there are herbal remedies available, like dong quai, black cohosh, licorice, and chasteberry, that can effectively manage some of the side effects of menopause. Nutritional approaches like supplemental vitamin A, C, and B vitamins, plus minerals like boron have also been shown to be effective.
Obviously the issues surrounding HRT are a long way from being resolved. But it's important to weigh the risks against the benefits when deciding how you want to proceed. While the debate continues, I'll keep you posted on further announcements from the Women's Health Initiative and their ongoing study of the effects of estrogen.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
"Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women" Journal of the American Medical Associaiton, 288:3, 7/17/02
"Citing Risks, U.S. Will Halt Study of Drugs for Hormones" Gina Kolata, New York Times, 7/9/02
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