The news hit the health community like a psychological tidal wave: Hormone-replacement therapy, or HRT, the once highly touted treatment for menopausal symptoms, had been found to increase the risk of breast cancer, heart disease and stroke--health problems the hormones were thought to alleviate.
The findings, drawn from the landmark Women's Health Initiative (WHI), were significant enough to prompt the research program to halt its study of 16,608 woman on estrogen and progestin replacement three years early and have led federal officials to launch a major reassessment of the risks and benefits of such therapies.
But the work of the WHI scientists is far from over. In fact, the exciting work is just beginning. "One of the areas I see behavioral scientists having a real important role to play is to help women use this information to make decisions about protecting their health after menopause," says Jennifer Hays, PhD, a principal investigator and psychologist with the WHI, which is funded by the National Institutes of Health's National Heart, Lung and Blood Institute.
Other psychologists are planning to examine a host of behavioral factors from the estrogen and progestin replacement trial, such as how the trial's cancellation is affecting its participants. Such ancillary studies will examine much more than the health risks and benefits detailed in the July 17 Journal of the American Medical Association (Vol. 288, No. 3) article, which explained why the study cancelled the estrogen and progestin treatment.
Behavioral researchers are planning to mine the WHI estrogen and progestin replacement therapy study data in several areas:
Whether women decide to continue HRT and why.
How HRT affected women's quality of life.
HRT's relationship with Alzheimer's disease.
Whether HRT is related to normal cognitive aging or dementia.
How factors at baseline, such as depression or smoking, related to disease outcomes.
What study condition--HRT or placebo--women thought they were assigned to and why.
What may have caused some women in the trial to feel a placebo effect.
Moreover, WHI is still conducting several other clinical trials, including examining the effects of vitamin D and calcium supplements on bone fractures and colorectal cancer, the effects of a low-fat diet on breast cancer, colorectal cancer and heart disease, and an observational study of 93,600 women to identify predictors of disease. A trial on the effects of estrogen-only HRT on women with no uterus and several ancillary studies are also continuing.
Even in the trials that examine physical outcomes, there's a wealth of behavioral knowledge, says Sally Shumaker, PhD, another WHI principal investigator. For example, behavioral scientists have been interested in what kinds of supports are necessary for women to maintain a low-fat diet over the 10 years of the study.
"Behavioral scientists have a very important role in the adherence aspects of the study, working out protocols and strategies to help increase adherence as well as retention of participants," explains psychologist and WHI principal investigator Judith Ockene, PhD.
There's also room for psychologists to re-examine many behavior-based interventions for the health risks HRT can aggravate. "Rather than relying on one pill to help women reduce their risk, now we're back to where we were before," says Hays. "Back to helping people become less sedentary, better eaters, give up smoking, to be compliant with other regimens for blood pressure or diabetes. These are things that behavioral science and behavioral medicine have done for a long time...and become even more important now."
Indeed, psychologists are adding much to the picture, says WHI principal investigator Robert Brunner, PhD. "The fact that we have several psychologists directing centers in this huge clinical trial is really remarkable," he says. "That's a role that some years ago we wouldn't have had open to us."