Options for women suffering in silence
Uterine fibroids may be benign, but they’re far from harmless.
These tumors, growing inside a woman’s uterus, can be as small as a pea or as large as a melon. They can cause cramps, bloating, pain during intercourse, miscarriages and vaginal bleeding so heavy that it can lead to anemia. Many sufferers feel the urge to urinate frequently, even in the middle of the night, because the fibroids press against their bladders.
Although one in four women of childbearing age suffers from the condition, treatment options are limited. The few medications used to treat fibroids have unpleasant side effects and can be used only to provide temporary relief.
Each year, more than 240,000 women opt for surgery to stop their suffering; many sacrifice their fertility as well.
Two experimental drugs that are now in human tests may offer a solution for some women, alleviating harsh symptoms and decreasing tumor size without the downsides of current treatments.
“These could be the first real medications to treat fibroids without serious side effects, which would help reduce the number of surgeries,” said Dr. Alison F. Jacoby, director of the Comprehensive Fibroid Center at UC San Francisco, who is testing one of the drugs, Asoprisnil.
Scientists believe that fibroid growth is stimulated by the female hormone estrogen. When women go through menopause, their estrogen levels drop and the fibroids usually shrink or disappear. To duplicate this reaction, doctors often prescribe steroids to treat smaller tumors. These drugs cut off the supply of estrogen, reducing the size of the fibroids and thereby easing symptoms.
Such medicines can’t be used for more than six months, however, because they also cause menopausal symptoms, such as hot flashes and bone loss. Larger fibroids can be removed surgically, but these invasive procedures carry a risk of infection, and most operations result in a loss of fertility.
“Many women just suffer in silence because they don’t want surgery,” Jacoby said.
The two compounds being tested work by blocking the action of progesterone, another female hormone that may fuel fibroid growth. Unlike other drugs used to treat fibroids, they don’t appear to induce menopausal symptoms.
“People aren’t getting those kind of side effects,” says Dr. Lynnette K. Nieman, who is testing one of these drugs, called CDB-2914, at the National Institute of Child Health and Human Development in Bethesda, Md.
CDB-2914, being tested by 36 volunteers, is in the second stage of clinical trials. The other drug, Asoprisnil, is further along in development. In a 2003 clinical trial of 129 women ages 18 to 49, half were given a placebo while the other half took Asoprisnil once a day for 12 weeks.
In the group taking the drug, tumor size was reduced by an average of 36%. Asoprisnil treatment also lessened bloating and pelvic pressure and stopped the abnormal uterine bleeding, known as menorrhagia.
Asoprisnil is in the final stage of clinical trials on 750 women at several research centers in preparation for applying to the Food and Drug Administration for approval for sale. The test should be finished at the end of this year, according to the drug’s maker, TAP Pharmaceutical Products Inc. in Lake Forest, Ill., and results may be available in the spring 2005. If all goes well, the drug could be available in 2006.
Questions remain about the drugs’ long-term effects.
“As soon as you stop taking the drugs, the fibroids come back. So women will need to be on them for years,” said Dr. Alan DeCherney, a professor of obstetrics and gynecology at UCLA’s Geffen School of Medicine. “But they may be good for women who don’t want to undergo surgery and want to preserve their fertility.”
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Existing treatments have their downsides
Anti-estrogen hormones that shrink fibroids can be used for only short periods. For more permanent relief from fibroids, about 200,000 women undergo hysterectomies every year, and 40,000 others choose a less invasive alternative, the myomectomy, which entails removing only the tumors.
Both have their downsides. A hysterectomy prevents a woman from having children. A myomectomy leaves the uterus intact so that women can still get pregnant, but the fibroids often return. Furthermore, the removal of larger tumors can cause uncontrollable bleeding.
In a newer procedure, called uterine artery embolization, a doctor inserts a catheter into the uterine artery. A compound, injected through the catheter, then plugs up the larger blood vessels that feed the fibroids, sparing almost completely the smaller vessels supplying the muscles in the uterine walls. Deprived of their blood supply, the fibroids eventually die and are reabsorbed by the body.
But with this treatment too, larger tumors may be difficult to eradicate.
