New pill helps vanquish fibroids

The first pill to treat uterine fibroids, a common problem in pre-menopausal women, has performed well in two European clinical studies. Esmya, which is a low-dose version of the emergency birth control pill called ella, is awaiting market approval in Europe and must still be tested in the U.S. However, this latest research suggests that there may finally be a satisfactory non-surgical treatment for this painful condition that can cause heavy bleeding, fertility problems, and is the leading cause of hysterectomies.

Two separate studies, both published in the New England Journal of Medicine, each used different methods to test the efficacy of the new drug. One study compared two different doses of Esmya with a placebo pill over the course of three months, while the other study tested Esmya against a hormone-blocking shot that is currently used to treat uterine fibroids, but whose side effects are problematic. In both studies, Esmya stopped the bleeding and shrank fibroids in about 90 percent of the 550 pre-menopausal women whose fibroid symptoms would otherwise require surgery. What s more, while the fibroids began to grow again after treatment was stopped in the hormone-blocking shot group, six months later the growths had still not reocurred in the women who were given Esmya. Also importantly, the new drug caused fewer side effects especially hot flashes than the hormone-blocking shot.

The study results are especially good news because, currently, removal of the uterus is the only cure for the condition (although sometimes satisfactory results occur from a lesser procedure involving removal of the fibroid growth alone). Researchers from the Saint-Luc Hospital at the Catholic University of Louvain in Brussels are now studying whether Esmya could be used on a long-term basis, given periodically as needed until menopause which is when the condition typically resolves itself.

ACSH s Dr. Gilbert Ross, noting the high prevalence of uterine fibroids which have been shown to eventually occur in about one-half of women by the time they reach menopause feels that an effective and safe oral treatment cannot come too soon. He d also like to see a study that examines how reliably women treated with Esmya regain their fertility. That seems like an important outcome point for this treatment, he remarks. Of course, women with fibroids can have normal pregnancies, but they do have an increased risk of infertility and pregnancy complications.