Conservative Treatment for Fibroids

What Are the Treatment Options for Fibroids?
If you need treatment for fibroids, there are a number of options available to you. Your choices should be guided by the medical problems the fibroids are causing, your desire to have children, and your feelings and thoughts about surgery or other options. I think it is important for you to know all the options available. Even if some treatments do not apply at the current time, your condition or symptoms may change. If you understand the potential for future symptoms and problems, as well as the alternative means of treatment available, much of the mystery of fibroids will disappear. 

Can My Fibroids Just Be Watched?
Although most women will have fibroids during their lifetime, only a small number of them will ever need treatment. The vast majority of women with fibroids are unaware of them until their doctor feels them at the time of a routine exam. Some women have very minor symptoms, which are not bothersome at all. If that is the case for you, then no treatment is necessary. I consider careful observation to be the primary treatment option.  

The cause of the growth of fibroids is not well understood, and the rate of growth is unpredictable. Most fibroids never grow; others grow gradually over the course of many years; and some seem to go through growth spurts and then may stop growing entirely. The only way to know what is happening is to have a pelvic examination on a regular basis. I usually examine women with fibroids every three to six months. If the fibroid grows during that time period, the growth will be discovered early, and a number of options, short of hysterectomy, should still be available. If the fibroid seems to be growing, I usually do exams more frequently, generally every month, until the growth stops. Ultrasonography, a simple test that uses sound waves to make a picture, may also be used to determine the size of the fibroids.

On the other hand, fibroids may sometimes grow large enough to cause constant discomfort, pressure, and even pain. And, while not dangerous, the discomfort may lead you to choose surgery as treatment for fibroids. One added note: very large fibroids may partially block blood flowing from the legs back to the heart. This can lead to swelling of the legs and some discomfort. Very rarely, it can also lead to formation of blood clots in the legs that can be dangerous. If you have very large fibroids, it is important that you not sit for prolonged periods of time so that clots have less chance to form.

What If You Have Large Fibroids?
Doctors have been taught that if a woman has fibroids the size of a large grapefruit (or a twelve-week pregnant uterus) or larger, she would be at risk for other health problems. This reason-the future possibility of problems-simply does not make sense to me. If you have a large fibroid and you are feeling fine, I can't see the need for you to undergo surgery. It is actually likely that your large fibroid will never go on to cause you any bothersome symptoms.  

Doctors also feel that large fibroids make it very difficult to perform a thorough pelvic examination and fear that a less than optimum pelvic examination can result in missing an early diagnosis of ovarian cancer. Unfortunately, ovarian cancer is extremely difficult to diagnose in the early stages, with or without fibroids, even with the most sophisticated and expensive testing (see A Gynecologist's Second Opinion : http://www.gynsecondopinion.com/ - Ovarian Cancer chapter) .

This is a frustrating and difficult reality for us all. Usually, by the time a gynecologist can feel an abnormality of the ovary during the pelvic exam, the disease has already spread. It is also common for gynecologists to not be able to feel every patient's ovaries because of the size of the ovaries, the position of the ovaries, or the weight of the patient. It would make no sense to recommend a hysterectomy to every woman whose ovaries were unable to be felt by her gynecologist. And no study has ever shown that removal of a uterus enlarged with fibroids will make any difference in the early detection of ovarian cancer.

Another argument for aggressive surgery relates to the belief that the risks and complications of surgery are greater if the surgery is delayed and the uterus grows larger. As shown in a recent study by Dr. Robert Reiter of the University of Iowa College of Medicine, the complication rate for women who have hysterectomies for large fibroids is no different from that for women with small fibroids. A myomectomy may be safely performed on a woman with large fibroids.

Dr Stanley West, Dr. Reginald Ruiz and I just submitted an article for publication reviewing the results of 91 women with uterine fibroids larger than a four month sized pregnant uterus operated on by Dr. West between 3/1/98 and 2/28/03 . The results compare very favourably to other studies of women who had a hysterectomy for large fibroids.

Therefore, surgery is only reasonable if you have symptoms that truly warrant the risk, time, stress, and money that an operation entails. Many patients with uterine fibroids need no treatment.

Can You Take Medication for Fibroids?
Unfortunately, there are no medications currently available that are able to prevent the formation of fibroids or permanently shrink them once they are present. Medicines are often used to buy time or reduce symptoms. For some women, a reduction in discomfort is enough to indefinitely postpone surgery. For others, medication allows a more relaxed time period to prepare emotionally and physically for an inevitable surgery. Medications may also temporarily reduce the size of the fibroids enough to allow for a less invasive surgery with a quicker recovery. For some women who are approaching menopause, the "bought time" may lead them right into menopause, when the natural loss of estrogen and progesterone shrinks the fibroids.

Lupron and Synarel are two of the medications that work by temporarily shutting off the ovaries' ability to make estrogen and progesterone, and menstrual periods temporarily cease. Since estrogen and progesterone are necessary for fibroids to grow, the lack of hormones causes fibroids to shrink. Because these medications are destroyed by digestive fluids in the stomach, they must be given in a non-pill form. Lupron is given by injection, and Synarel is administered by nasal spray.  

These medications take about two weeks to begin shrinking the fibroids, and the full effect is seen after three months. At that time, most fibroids will decrease in size by about 50 percent of their volume. The shrinking effect is maintained for as long as you use the medication, but there is rarely any further shrinkage after the third month of treatment. If the medication is stopped, the ovaries begin to produce hormones again and the fibroids return to their original size within three months. Therefore, the medication has no permanent effect and is primarily used to reduce symptoms and allow time to correct anemia and plan surgery. In addition, long-term use of these medications is limited by their side effects and the risk of osteoporosis. 

Two medications used to treat uterine fibroids are now in clinical trials. Both drugs act by blocking the growth-promoting action of progesterone on fibroids. The first drug is RU-486, also known as the abortion pill. This medication is being studied in Rochester , NY and the researchers have found about a 50% reduction in fibroid size after taking this oral medication. Because the drug blocks progesterone but not estrogen, the estrogen from the ovaries can stimulate the lining cells of the uterus without any counter action by the progesterone. After a year of treatment, about 5% of women had overgrowth of these lining cells, although no one developed pre-cancer or cancer. There is some concern that continued use of this medication might eventually lead to pre-cancer or cancer, but again, this has not been found so far. Other side-effects include hot flashes and headache.

I am including the abstract

Low-dose mifepristone for uterine leiomyomata.
Authors: Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS.

Obstet Gynecol. 2003 Feb;101(2):243-50

OBJECTIVE: To compare the effect of 5 and 10 mg of mifepristone on uterine leiomyoma size and symptoms, and to measure side effects.

METHODS: Forty premenopausal women with large, symptomatic leiomyomata were randomized to receive either 5 or 10 mg of mifepristone daily for 6 months in an open-label study. Uterine volume was measured at bimonthly intervals by sonography. Serum concentrations of hemoglobin levels, follicle-stimulating hormone, and liver enzymes were obtained, and endometrial samples, symptoms, and menstrual bleeding were also assessed.

RESULTS: Nineteen of 20 subjects taking 5 mg and all 20 subjects taking 10 mg completed all 6 months of the study. Mean uterine volume shrank by 48% (P <.001) in the 5-mg group and 49% (P <.001) in the 10-mg group, a nonsignificant difference. Leiomyoma-related symptoms were comparably reduced in both groups. Amenorrhea occurred in 60-65% of both groups. Hemoglobin levels increased by 2.5 g/dL in anemic subjects. The incidence of hot flashes increased significantly over baseline in the 10-mg group but not in the 5-mg group. Simple endometrial hyperplasia occurred in 28% of all subjects, with no difference between groups. No atypical hyperplasia was noted.

CONCLUSION: Mifepristone in doses of 5 mg or 10 mg results in comparable leiomyoma regression, improvement in symptoms, and few side effects. Further study is needed to assess the long-term safety and efficacy of low-dose mifepristone.

The other progesterone blocking drug is Asoprisnil. Early results also show about a 50% shrinkage in fibroid size.

I am including the only published abstract so far (funded by TAP the company that makes the drug):

Asoprisnil (J867): a selective progesterone receptor modulator for gynecological therapy.

Authors: DeManno D, Elger W, Garg R, Lee R, Schneider B, Hess-Stumpp H, Schubert G, Chwalisz K.

Steroids. 2003 Nov;68(10-13):1019-32.

TAP Pharmaceutical Products Inc., 675 N. Field Drive , 600452, Lake Forest , IL , USA

Asoprisnil is a novel selective steroid receptor modulator that shows unique pharmacodynamic effects in animal models and humans. Asoprisnil, its major metabolite J912, and structurally related compounds represent a new class of progesterone receptor (PR) ligands that exhibit partial agonist and antagonist activities in vivo. Asoprisnil demonstrates a high degree of receptor and tissue selectivity, with high-binding affinity for PR, moderate affinity for glucocorticoid receptor (GR), low affinity for androgen receptor (AR), and no binding affinity for estrogen or mineralocorticoid receptors. In the rabbit endometrium, both asoprisnil and J912 induce partial agonist and antagonist effects. Asoprisnil induces mucification of the guinea pig vagina and has pronounced anti-uterotrophic effects in normal and ovariectomized guinea pigs. Unlike antiprogestins, asoprisnil shows only marginal labor-inducing activity during mid-pregnancy and is completely ineffective in inducing preterm parturition in the guinea pig. Asoprisnil exhibits only marginal antiglucocorticoid activity in transactivation in vitro assays and animal models. In male rats, asoprisnil showed weak androgenic and anti-androgenic properties. In toxicological studies in female cynomolgus monkeys, asoprisnil treatment abolished menstrual cyclicity and endometrial atrophy. Early clinical studies of asoprisnil in normal volunteers demonstrated a dose-dependent suppression of menstruation irrespective of the effects on ovulation, with no change in basal estrogen concentrations and no antiglucocorticoid effects. Unlike progestins, asoprisnil does not induce breakthrough bleeding. With favorable safety and tolerability profiles thus far, asoprisnil appears promising as a novel treatment of gynecological disorders, such as uterine fibroids and endometriosis.

Can Lupron Be Used for Women Approaching Menopause?
A woman with fibroids who is approaching menopause can use Lupron or Synarel until menopause begins. Then the natural supply of estrogen will cease, and the fibroids will remain small without any medication. However, because the exact age of natural menopause is unpredictable, this can turn into an expensive proposition-$2,000 per year-and is usually not covered by medical insurance. But, for some women, this treatment plan may be useful.  

Are There Any Other Promising Medications on the Horizon?
Pirfenidone is a new, not yet available, medication that blocks the growth of existing fibroids and may stop the formation of new fibroids. Although the exact mechanism of action is not known, pirfenidone affects the production of collagen, a major component of fibroids. Other effects of pirfenidone on cell growth factors may also be important. Studies are now under way to evaluate how fibroids respond to this new drug and to evaluate its side effects. In the future, women with small fibroids may be able to take pirfenidone, or a medication like it, to prevent fibroid growth and avoid any other need for treatment.

Can Focused Ultrasound Be Used to Treat Fibroids?
Ultrasound is a form of energy, and when used at high intensity and focused on an object, the energy can be used to destroy that object. This principle has recently been used in experiments for the treatment of fibroids. The ultrasound energy is generated outside the body but focused on a fibroid in the uterus. The procedure presently takes a few hours to treat each fibroid. The size of the fibroid that can be successfully treated is limited to about a two-inch (5cm) diameter. This procedure is in its early development. We hope these techniques can be refined so that the procedure time will be shorter, and the size of the treated fibroid can be larger.

Please visit Dr. Parker's site at A Gynecologist's Second Opinion