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Uterine Fibroids and Mifepristone
Uterine fibroids are noncancerous or benign tumors
that arise from the muscular wall of the uterus. Approximately
70 percent of all women have fibroids (1)
and 25 percent of those women have symptoms due to the
presence of fibroids.(2) Fibroids
develop in women of all "races" yet for some
unknown reason they are two to three times more prevalent
among African American women. (3)
Fibroids remain the single most common indication for
hysterectomy in the United States, accounting for approximately
30 percent of the 600,000 hysterectomies performed in
the U.S. annually, at an estimated expense of greater
than one billion dollars per year.(4)
Symptoms
| Treatment | Mifepristone
| Notes | Take
Action
Symptoms
Uterine fibroids, also known as myomas,
tend to become more symptomatic as women age with the
peak incidence for hysterectomies due to fibroids occurring
around age 45.(3) The major symptoms
associated with fibroids are heavy menstrual bleeding
(causing anemia in many cases), pelvic pain, pain during
sex and a frequent need to urinate. Fibroids can sometimes
cause problems becoming pregnant and maintaining a pregnancy.
Fibroid growth seems to be dependent on hormonal fluctuations.
Fibroids have been observed to grow rapidly during pregnancy
and they often shrink after menopause when hormone levels
decrease considerably.
Treatment
Medical (drug) treatment has consisted
largely of Lupron, a hormonal treatment that essentially
induce a menopausal state. By stopping the hormonal
fluctuations that induce periods, Lupron temporarily
causes a significant reduction in the size of the fibroids
and also can prevent the anemia associated with the
excessive fibroid-related menstrual bleeding.(3)
While it is the most common medical treatment for fibroids,
Lupron has not been approved by the FDA to reduce
fibroid size. Rather, doctors use it "off-label"
in attempt to shrink uterine fibroid size and improve
anemia prior to fibroid-related surgery. Lupron is administered
in a monthly shot or taken as a nasal spray. Side effects
include significant hot flashes and diminished bone
mineral density. This bone loss can take up to two years
to be restored after treatment with Lupron.(5)
Surgical and interventional radiology
treatment options are more plentiful than medical options.
Options include(2) :
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Hysterectomy: Removal of the entire
uterus (with or without removing ovaries).
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Myomectomy: Removal of the fibroid/s
while preserving the uterus.
-
Fibroid Myolosis: Similar to myomectomy
but the fibroid is zapped with electricity which constricts
the blood vessels and cuts off the blood supply to
the fibroid.
-
Endometrial ablation: Removal of the
uterine lining with our without myomectomy. This helps
stop excessive bleeding but doesn't treat many symptoms
due to fibroid size.
-
Uterine-artery Embolization: Performed
by an interventional radiologist, the uterine artery
supplying blood to the fibroid is blocked causing
it to shrink. This is somewhat similar to fibroid
myolosis.
At a rate of 5.6 per 1000 women, the U.S. hysterectomy
rate is three to four times higher than that of most European
countries, Australia and New Zealand (6).
Only 11 percent of hysterectomies are performed because
of cancer (7). According to the American
College of Obstetricians and Gynecologists, the U.S. rate
of hysterectomy did not change significantly from 1990 to
1997 with hysterectomy remaining the most common nonpregnancy-related
surgical procedure in the United States (6).
A recent study presented at the Society of Cardiovascular
and Interventional Radiology meeting stated that in a head-to-head
comparison with hysterectomy, uterine artery embolization,
a "minimally-invasive" procedure is as effective
as hysterectomy in treating fibroids (8).
The study results are being submitted to the FDA in order
to approve uterine artery embolization as a safe and effective
treatment for fibroids. Studies presented at the conference
highlighted the unfortunate fact that most gynecologists
do not tell their patients about this less invasive procedure,
or they tell them only negative aspects of the procedure.
Women undergoing the procedure had usually heard of it from
friends or newspaper articles. Part of the problem may be
that because the embolization procedure is performed by
a radiologist, many gynecologists do not know of the procedure
or do not know enough about it (8).
Despite the medical or more invasive fibroid treatments,
uterine fibroids frequently reappear even after surgical
or medical therapy. After stopping hormonal medications,
fibroid size usually returns to pre-treatment levels within
several months and the long-term recurrence rate 10 years
after myomectomy is 27 percent (9).
Clearly, less invasive treatments with fewer side effects
need to become available. The Feminist Majority Foundation
believes that mifepristone is a critical option for women
that must be further studied.
Mifepristone
Studies with mifepristone, a drug that blocks the effects
of the hormone progesterone, indicate that when compared
to the present medical standard of care, Lupron, three months
of mifepristone was as effective as six months of Lupron
in causing a 50 percent shrinkage in fibroid size (10).
Moreover, it was much better tolerated, causing minimal
hot flashes. Furthermore, because it doesn't suppress estrogen
levels as Lupron does, mifepristone does not cause loss
of bone density. Additionally, mifepristone is approximately
1/7th the cost of Lupron!
Larger clinical trials validating mifepristone's effectiveness
and safety in treating fibroids have been brought to a standstill
due to anti-abortion politics. The Feminist Majority
Foundation has launched the "Mifepristone and Women's
Health" campaign, calling for more clinical trials
exploring mifepristone's medical potential in treating numerous
conditions that primarily affect women: breast cancer, uterine
cancer, ovarian cancer, endometriosis, and uterine fibroids.
Fibroid research with mifepristone is critical in providing
women with a better tolerated, safe and effective non-surgical
alternative in the management and treatment of fibroid tumors.
The Feminist Majority Foundation fully supports Senator
Jean Carnahan and her co-sponsors, Senators Barbara Mikulski
(D-MD) and Jim Jeffords (I-VT) in pushing for more research
on uterine fibroids and we ask that further clinical trials
with mifepristone be a vital part of that research. Show
your support for legislation that would increase funding
for uterine fibroid reasearch: Take
Action Today!
Notes
1 National Institutes of Health; National Institute of
Environmental Health Sciences
2 Stewart, E. MD, Lancet; "Seminar in Uterine
Fibroids", 2001;357:293-298
3 Speroff, L. MD, Glass, R. MD, Kase, N MD, Clinical
Gynecologic Endocrinology and Infertility, Lippincott
Williams and Wilkins, 1999. p.149.
4 American College of Obstetricians and Gynecologists.
"Uterine Leiomyomata. ACOG Technical Bulletin No. 192.
Washington DC: American College of Obstetricians and Gynecologists,
1994.
5 Speroff. p.1067.
6 ACOG News Relase, January 31, 2002
7 CDC website. August 8th, 1997. "Special focus: Surveillance
for Reproductive Health; Hysterectomy Surveillance-U.S."
8 Kaisernetwork.org, April 9, 2002
9 Speroff. p.151.
10 Murphy, A MD, Kettle, M MD, et al, "Regression
of Uterine Leiomyomata in Response to the Antiprogesterone
RU-486", Journal of Clinical Endocrinology and Metabolism,
Vol. 76, No. 2, 1993
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Uterine fibrouids affect 70% of all women
Uterine fibroids account for 30% of the 600,000 annual
hysterectomies performed in the U.S.
Studies suggest that minimally-invasitve procedures
are as effective as hysterectomy in treating fibroids
Mifepristone, a non-invasive, hormonal treatment, shows
promise as an effective, well-tolerated treatment method
for uterine fibroids
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