14 DAY TRIAL // A team of researchers at the University of North Carolina at Chapel Hill have started a new clinical trial to see whether estrogen replacement therapy could help prevent depression and cardiovascular disease in women who are in the menopause transition.
The study entirely conducted at UNC, began in August 2010 and its aim is to enroll a total of 320 women aged between 45 and 55 years, who will be randomized to receive treatment with estradiol (estrogen replacement) skin patches or placebo.
All the women part of the trial will be tested three times – once before the beginning of the treatment, and then again after 6 months and 12 months of treatment.
These tests will include assessing their cardiovascular and inflammatory responses to mental stress, and analyzing the indicators of cardiovascular health and metabolic markers like the glucose tolerance test, waist/hip ratio and lipid profiles.
Also, the moods, vital signs and conformation to the treatment regimen will be noted, for every participant.
This initiative could create a bit of debate, since a Women’s Health Initiative (WHI) study was stopped in 2004, because the researchers found that estrogen therapy increased the risk of stroke and blood clots.
However, there is a major difference between the UNC study and the WHI estrogen study, that needs to be mentioned, according to David Rubinow, MD, UNC’s chair of psychiatry and one of two principal investigators of the new 5-year study, funded by a $4.5 million grant from the National Institutes of Health.
He says that “the Women’s Health Initiative study led to the mistaken belief that estrogen replacement therapy is bad for all women.
“And as a result, it has served to deprive some women of a treatment that might greatly and favorably impact their lives.
“Much of the negative impact of estrogen that they found was related to the fact that most of the women in the Women’s Health Initiative study were far past the menopause and up to 79 years old.
“There are now a large number of studies that demonstrate what has been called the timing hypothesis.
“That is, giving estrogen within a year or two of menopause has beneficial effects, but giving estrogen in women more than five years beyond the menopause can actually be harmful.
“When the women who were close to menopause were looked at separately, the adverse effects on the heart were not seen and in fact some suggestion of beneficial effects was seen.
“Perimenopausal women in the Women’s Health Initiative who received estrogen had significantly lower coronary artery calcification compared to the women who didn’t take estrogen.
This research tries to find an answer to whether estrogen could be potentially beneficial for women in the perimenopause, but at this point, the question is still unanswered.
“Our study is an effort to find out what puts an individual woman at risk for heart disease and depression and what predicts beneficial effects of estrogen replacement during the perimenopause on affective well-being and cardiovascular well-being,” adds Dr. Rubinow.
“Given the mortality and morbidity associated with depression and heart disease, and the tremendous increase in risk of these disorders during the perimenopause, it is critical that we identify those women who will be helped by estradiol.”
The other principal investigator on the study is Susan Girdler, PhD, professor of psychiatry.