New Treatment for Menopause Symptoms
2-Drug Combo May Reduce Menopause Symptoms While Building Bone
What We Know Right Now
In the first of the two new trials being presented, researchers looked at the impact of TSEC on the endometrium (the lining of the uterus) in nearly 4,000 women aged 40 to 75 over the course of two years.
The study showed that new cases of endometrial hyperplasia (a thickening of the lining frequently associated with estrogen therapy and sometimes a precursor to cancer) were similar to placebo. Moreover, there was also no increase in bleeding and spotting or breast pain, all common side effects of hormonal therapy.
In the second study, doctors tested the same TSEC on bone mineral density (BMD). They found that it yielded a greater increase in bone mineral density of the spine and hip when compared with placebo or Evista, another SERM.
Menopause Symptom Relief
Though both studies offer promise, perhaps the aspect of TSEC that will interest most women is the potential improvement of menopausal symptoms -- problems like hot flashes or vaginal dryness.
"Two of the phase III trials looked at hot flushes, and the combination appears very effective in significantly reducing not only the number, but the severity," says Pickar. This is significant since SERM medications, particularly at high doses, often increase hot flashes.
Moreover, he adds that vaginal symptoms such as dryness and thinning also responded favorably to this TSEC. SERMs alone have no impact on these symptoms.
Although there have been no specific studies on either the protective effects or risks of TSEC on heart health, thus far Pickar says no adverse cardiovascular events have been reported. He adds that the incidence of blood clots and stroke previously associated with hormone therapy "was not different than placebo in our two-year trial of TSEC."
A head-to-head study comparing TSEC with HRT is under way with results expected later this year. Goldstein cautions that there is still much we don't know about this new approach to treating menopause.
"It could be the answer we have been searching for, but women need to realize that there are still many questions that need to be answered before we can say for certain this is a revolutionary treatment option."