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GETTING BETTER
Finding a treatment for fibroids
A surgical procedure, recently performed on Condoleezza Rice, minimizes tumors.

 

By Jacqueline Stenson
Special to The Times
November 29, 2004

When Patricia Caudle first began noticing that her menstrual periods were abnormal, she "just dealt with it." But after they began substantially interfering with her quality of life, she knew she needed help. The severe pain, irregularity of her monthly cycles and the unexpected and prolonged bleeding she experienced were causing difficulties at work — she sometimes had to dash out of meetings or go home early. And her social life was suffering. She was bailing out on engagements with friends and missing church and community theater activities. During an exam, Caudle, a human resources manager at a Los Angeles law firm, says her gynecologist noticed that her abdomen was unusually hard. MRI and ultrasound scans revealed that she had several large fibroids, masses that were equivalent in size to two big grapefruits. Fibroids are benign tumors that develop in the walls of the uterus. It's not clear how many women in the United States have fibroids, though it's estimated they may occur in up to three-fourths of American women, most of whom do not need treatment. But many women with severe symptoms do seek treatment, such as Secretary of State nominee Condoleezza Rice, who on Nov. 19 underwent a procedure known as uterine fibroid embolization, a relatively new minor surgery.
Studies suggest that 20% to 40% of women of reproductive age have fibroids that cause symptoms such as heavy bleeding, pelvic and back pain, fertility problems, frequent urination and constipation. Doctors don't know exactly why fibroids develop, although estrogen appears to promote the growth of these noncancerous tumors. Fibroids generally shrink after menopause, when estrogen production declines. In preparation for a procedure to treat the fibroids, Caudle received several months of hormone injections to
send her body into a menopausal state in an effort to reduce the size of her fibroids. But the tumors didn't seem to budge, and Caudle suffered hot flashes and night sweats, common menopausal symptoms that only added to her misery.
At the time, she was also taking iron supplements to treat her anemia. Caudle had considered having a hysterectomy, the removal of the uterus and the only guaranteed cure. She had also weighed a more conservative choice known as myomectomy, a procedure in which fibroids are surgically cut out of the uterus. But concerned about undergoing major surgery, Caudle decided on uterine fibroid embolization, also known as
uterine artery embolization, a newer, less invasive approach. During the procedure, a radiologist makes an incision in the groin and, using a special dye and X-ray imaging
for guidance, threads a catheter into the main uterine artery. Beads the size of grains of sand are then released to block the blood vessels that nourish the fibroids.
"The fibroids shrink and die over time," says Dr. Victoria Marx, an interventional radiologist at USC's Keck School of Medicine in Los Angeles, who treated Caudle in October 2002. During the procedure, Caudle received intravenous sedation, which made her sleepy but allowed her to remain conscious. She stayed in the hospital two days and didn't feel completely recovered until about seven weeks later. Many patients, however, are back to normal within a couple of weeks, Marx says. Until recently, Caudle's periods remained erratic. "If I did bleed, it would be unannounced," she says. "Then I didn't have periods for a while. It got to the point that I didn't think I'd ever have one again. It's been within the last few months that I think things are back to normal."
Caudle's periods now last about five days, as before, and the bleeding on the first couple of days is still quite heavy. The cramps she experiences are less severe than before she underwent treatment for fibroids. "Now it's just your normal cramping," she says. "I can manage it." And her menstrual cycle is back on track; her periods arrive pretty much every 28 days. She's happily regained an active social life. Her energy is back and she's able to plan activities without worrying that she'll have to cancel at the last minute because of debilitating bleeding and pain. She knows that uterine fibroid embolization isn't always a permanent cure. About 20% to 25% of patients will experience a recurrence at some point, says Marx, who underwent the embolization procedure for fibroids in 2001. But Caudle is hoping the effects of the procedure will carry her through to menopause. "They can always come back, but right now I'm comfortable," she says. "I'm not a nervous wreck at work anymore."

November 23, 2004

Treating Troubling Fibroids Without Surgery
By LAWRENCE K. ALTMAN
Condoleezza Rice, the national security adviser, shares at least one thing with millions of other American women: she had fibroids, benign tumors in the uterus that required treatment. Ms. Rice, the nominee for secretary of state, entered the hospital for an overnight stay last week to undergo a procedure - uterine artery embolization - that is rapidly becoming an alternative to major surgery for troublesome fibroids.
For most women, fibroids, consisting of muscle and fibrous tissue, are no bother. But for millions of others, fibroids can be so large (in some cases, the size of a melon) or so numerous that they cause discomfort, severe bleeding, anemia, urinary frequency and other symptoms.
What causes fibroids is unknown, although estrogen is known to promote their growth. More than one woman in five age 40 and older has the tumors, with higher rates among black women. For decades, major surgery - a hysterectomy to remove the uterus or a myomectomy to remove selected fibroids while leaving the uterus in place - was the main therapy for women whose symptoms were not controlled by oral contraceptives or other hormonal therapies. About 30 percent of the 600,000 hysterectomies performed in the United States each year are for fibroids.
With the introduction of technologies like ultrasound, C.T. scans, magnetic resonance imaging and new drugs, however, doctors have in recent years developed a number of alternative therapies.
This year in the United States, about 13,000 women are expected, like Ms. Rice, to choose the embolization technique, which is less invasive than surgery. French doctors first reported the embolization procedure in 1995. Since then, the number of the procedures has grown, in part because of direct-to-consumer advertising by interventional radiologists, who perform them. Embolization involves injecting pellets the size of grains of sand, made from plastic or gels, into uterine arteries to stop blood flow and shrink the tumors by starvation. The procedure is so named because the pellets are emboli, objects that lodge and stop blood flow. M.R.I. scans are often used to screen out fibroid patients
who are not candidates for the embolization procedure. In performing the procedure, interventional radiologists insert a thin tube into an artery in the groin and thread it up to the main uterine artery in the pelvis. A dye is injected that outlines the smaller arterial branches on an X-ray, producing a map that guides injection of pellets through the tube into the arteries that nourish the fibroids.
"Of the patients we see, at least a third have fibroids the size of an orange or larger," and the size does not influence the outcome of the procedure, said Dr. John H. Rundback, an interventional radiologist at Columbia University. The procedure, which may be painful, usually lasts 60 to 90 minutes. Most patients also experience intense pain for several hours afterward and stay overnight in the hospital. For some patients, the pain persists for
several days, or even two weeks. Surgery for fibroids requires a longer hospital stay.
Additional complications from the embolization procedure can include abscesses and other infections; heavy uterine bleeding; early menopause from the pellets damaging the ovaries; or destruction of the uterus, requiring emergency surgery.
Although the procedure is safe, "there are still significant uncertainties about the procedure, especially in terms of future fertility and long-term outcomes," said Dr. Evan R. Myers, chief of the division of clinical and epidemiologic research in Duke University's department of obstetrics and gynecology.
Judging the safety and effectiveness of embolization compared with to other therapies is hard because randomized controlled studies are lacking and because earlier studies did not report how different symptoms responded to different treatments, Dr. Myers said.
"It is amazing that for a condition as common as fibroids, that has such significant impact on reproductive-age women, there is not a lot of high-quality scientific evidence for many of the things that are done for fibroids," Dr. Myers said.
"There still is no gold standard randomized trial comparing embolization to the other interventions," he added. This is largely because patients and physicians have such strong preferences for one method or another that it is hard to recruit enough patients for clinical trials comparing the embolization procedure to hysterectomy, myomectomy, hormonal and other therapies. Dr. Myers directs a registry that the Society of Interventional Radiology has created to monitor the outcome of 3,000 women who have undergone the embolization procedure. He said that the effectiveness and complication rates for embolization seem comparable to surgery. But there is insufficient information to draw conclusions about the procedure's safety for women who desire to become pregnant, according to Dr. Myers, the interventional society and the American College of Obstetricians and Gynecologists. In very rare cases - less than 1 percent - fibroids are cancerous. The cancers usually develop among postmenopausal women and the embolization procedure is not recommended for that group. Biopsies are not routinely performed on fibroid patients before embolization, and even if they were done, biopsies would not be able to detect cancerous fibroids deep in the uterine muscle. So statistically, as more women undergo embolization procedures, the cancers are unlikely to be detected in the very few patients who have them. "That small risk has to go into the counseling before the embolization procedure," said Dr. Howard T. Sharp, chief of the general division of obstetrics and gynecology at the University of Utah.
Dr. Sharp said he believed that there were probably more cases of cancer than the single report in the medical literature, because doctors often "don't report the bad outcomes."
While some researchers are trying to study the embolization procedure further, others, like Dr. Elizabeth Stewart of the Brigham and Women's Hospital in Boston, are testing another fibroid treatment, the ExAblate 2000 System, that won approval from the Food and Drug Administration last month. The system, made by InSightec Ltd. of Israel, uses ultrasound to destroy the fibroids with heat and M.R.I. to map the uterine anatomy and monitor the degree of fibroid destruction from a repeated application of multiple
ultrasound waves on the tumor. The device centers the ultrasound waves similarly to the way a magnifying glass focuses light.
The patient remains in an M.R.I. machine for about three hours and then can go home. Initial studies found that serious side effects occurred in 2 percent of cases, compared with 13 percent among women who underwent a hysterectomy, Dr. Stewart said. Additional studies are being conducted at a small number of hospitals. The procedure is intended for women who have completed childbearing or who do not intend to become pregnant.