For years, doctors had eagerly awaited answers about hormone replacement therapy’s health benefits from a large government study.
Now that the main answers are in, some of those same doctors have been criticizing the study, leaving scientists involved in the research shaking their heads.
”People openly just wanted it to come out differently, and they’re having a hard time facing it,” says one of the researchers, obstetrician/gynecologist Susan Johnson of the University of Iowa.
On July 9, the government-sponsored Women’s Health Initiative announced that it was halting its study of estrogen plus progestin three years early because of an increased risk of breast cancer ( news – web sites) in women taking the hormones. And earlier analyses had found that heart attack risk began rising in the hormone group almost from the beginning of the study.
”If this were a new drug that no one had ever heard of . . . and you came up with exactly these same results, it would just be abandoned,” says Johnson. ”But what we have here, instead, is a drug that’s been around for 50 years that people have very deeply ingrained beliefs about.”
Skeptical doctors have been questioning the wisdom of stopping the study early. They note that the increased breast cancer risk for each participant was slight. They point out that colorectal cancer and hip fractures decreased in the estrogen-progestin group.
And they wonder whether lower doses or other formulations might have performed better.
”I’m getting letters saying ‘How dare you publish this without also publishing a rebuttal?’ ” says Catherine DeAngelis, editor of the Journal of the American Medical Association ( news – web sites), which posted the study on the Web on July 9 and published it July 17. ”What rebuttal?”
The Women’s Health Initiative randomly assigned more than 16,000 women who had not had a hysterectomy to take either Prempro, the top-selling brand of estrogen plus progestin, or a placebo.
The letter-writers, says DeAngelis, have only anecdotal information gleaned from their patients.
That level of evidence pales next to the findings of a randomized controlled trial such as the Women’s Health Initiative, DeAngelis says. ”Give me the evidence (that HRT protects against heart attacks), and I’ll publish it tomorrow.”
Jacques Rossouw, acting director of the Women’s Health Initiative, says he’s heard the stories about how confused doctors and their patients are over the study’s results.
”My reply to that is this actually cuts through the confusion,” Rossouw says. While HRT is the best remedy for menopause symptoms, he says, women should not take it any longer than necessary.
Rossouw says he can’t fathom how anyone would ask study participants to continue taking hormones in light of the breast cancer risk.
As for lower doses of hormones, Rossouw says, ”it’s possible that you’d show lower risks, but you’d also probably show lower benefits.”
Although women in the estrogen plus progestin trial have stopped taking their pills, the study is far from over, Rossouw says. He says the Women’s Health Initiative researchers already have 27 more papers that have been or will be submitted to scientific journals.