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Fibrocystic Breast Disease
Hormone Replacement and Breast Cancer
In the July 17, 2002 edition of the Journal of the American Medical Association, after decades of accumulated observational evidence, the Women's Health Initiative Investigators group raised concerns about the balance of risks and benefits for hormone use in healthy postmenopausal women. The concerns resulted from a randomized controlled primary prevention trial. The trial recruited 16,608 postmenopausal women (50-79 years of age) with an intact uterus at age 40 to United States clinical centers from 1993-1998. The study was designed to last 8.5 years. Participants in the study received placebo (8102 subjects) or conjugated equine estrogen (0.625 mg daily) plus medroxyprogesterone acetate (2.5 mg daily) in a single tablet (8506 subjects), commonly known as Prempro. The study monitored coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes.
After 5.2 years, the data and safety monitoring board recommended stopping the trial because one statistic (for invasive breast cancer) had exceeded the stopping boundary for an adverse effect and the global index statistic supported risks exceeding benefits. Although the absolute risk was still low, investigators stopped the estrogen plus progestin part of the study. They concluded: "Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal U.S. women." Women in the other groups in the study (women taking estrogen alone, on a low-fat diet, taking calcium and vitamin D supplements, and women in the observation-only group) were advised to continue with their assigned treatment regime. However, prescribing the combination of estrogen and progestin was not recommended for long-term use or for prevention of chronic diseases (Women's Health Initiative Investigators 2002). Theories abound about why there appear to be complications with combination HRT, with one being that the progestin part of the therapy may have an antagonistic action on the estrogen part. Other co-factors include obesity, diabetes, and influence of family health history.
Another much smaller study in 2001 (158 women: 58 using HRT with Prempro (conjugated equine estrogen, 0.625 mg, plus medroxyprogesterone acetate, 5 mg); 51 using low-dose oral estrogen alone (estriol), 2 mg daily; and 55 using transdermal estrogen via a patch with estradiol, 50 mcg each 24 hours) evaluated the impact of different HRT regimens on mammographic breast density. Independent radiologists were unaware of the HRT and analyzed coded mammography films. The research indicated that an increase in mammographic density was more common in women taking continuous combined HRT (40%) than in those using oral low-dose estrogen (6%) or transdermal (2%) treatment (Lundstrom et al. 2001). The researchers reported that increased density was already apparent at the first visit after beginning HRT. During long-term follow-up, there was very little change in mammographic status, leading Lundstrom et al. (2001) to conclude that there was an "urgent need to clarify the biological nature and significance of a change in mammographic density during treatment and, in particular, its relation to symptoms and breast cancer risk."
Scientists, environmentalists, physicians, and governmental agencies have all produced reports in support of their particular stance on hormones: are they safe or not and should they be used or not? Therefore, in light of continuing concerns about the safety of using HRT, particularly HRT containing estrogen plus a progestin component, decisions concerning hormone use and modulation are personal ones related to each woman's particular risk factors and her reasons to consider using HRT. It is more important than ever to consult your physician for guidance concerning the decision to use any hormone therapy (also see the Female Hormone Modulation Therapy protocol).
Signs of Breast Cancer
Nodules that are hard, poorly delineated, and fixed to the skin or to underlying tissue are suggestive of breast cancer. Cancerous nodules can cause dimpling, nipple deviation, or nipple retraction. They usually occur singly and often are not painful. There may be nipple discharge that is clear or bloody. Bloody discharge is more suggestive of breast cancer. Ulceration may occur in later stages (Anon. 2000). (Further discussion of breast cancer is beyond the scope of this protocol. See the Breast Cancer protocol for a discussion of additional information.)
OTHER CAUSES OF BREAST NODULES
Mastitis or postpartum mastitis is an infection in women who are breastfeeding in which a milk duct becomes blocked, causing milk to pool, permitting a bacterial infection, and resulting in inflammation (AMA 1989). The breast appears red and feels warm and may also be tender. Mastitis can be accompanied by chills, fever, and cracking of the nipple.
Mammary Duct Ectasia
Mammary duct ectasia causes ducts beneath the nipple to become clogged and inflamed, particularly in women nearing menopause or in postmenopausal women (National Cancer Institute 2001b). The condition can be itchy and tender, with transient pain, and it may produce a thick, sticky multicolored discharge. The skin over the nodule may even be a blue-green color. Nearby lymph nodes can also be inflamed.
Pseudolumps
Pseudolumps are normal lumpy areas of breast tissue. This type of lumpiness will often disappear or vary with cyclic hormonal levels. Pseudolumps also result from silicone injections to enlarge the breasts or as a consequence of breast surgery or radiation therapy.
Fat Necrosis
Fat necrosis produces painless, round, firm lumps that form from damaged and disintegrating fatty tissue (National Cancer Institute 2001b). Fat necrosis is more likely to occur in obese women with large breasts. It may also develop in response to a bruise or blow to the breast. Sometimes the skin around these lumps looks red or bruised.
Breast Pain
Mastalgia refers to breast pain that is severe enough to cause a woman to seek medical treatment. Mastalgia can occur at rest or during movement, intermittently, cyclically, or constantly and can be sharp or dull and radiate to the back, arms, or neck. Pain can be aggravated by palpation (such as during physical examination). However, mastalgia is an unreliable indicator of a serious condition such as cancer (Anon. 2000). Although many women experience uncomfortable tenderness and swelling, pain characterized as severe occurs only about 15% of the time.
Breast pain not related to the menstrual cycle is called non-cyclical breast pain. Non-cyclical breast pain is rare and much more difficult to treat. Non-cyclical breast pain can be caused by old trauma to the breast (such as a blow to the breast, a biopsy, or surgery), infection, or some other condition completely unrelated to the breast (Anon. 2000). Arthritis is a possible cause of breast pain. Arthritis pain is usually felt in the breastbone, at the center of the chest. Women with arthritic breast pain also may experience increased discomfort when they breathe deeply.
An early study showed that there were significant abnormalities in pituitary function (via prolactin mechanisms) seen in severe cyclical mastalgia and nodular breast disease, but not in women with noncyclical mastalgia (Kumar et al. 1984).
DIAGNOSING FIBROCYSTIC BREAST DISEASE
A healthcare provider who is experienced in diagnosing breast conditions should examine any new breast mass or lump. Additionally, if there is any skin irritation, dimpling, nipple pain or retraction, redness or scaling of the nipple or breast skin, or nipple discharge other than breast milk in lactating women, see a physician for an evaluation. Breast conditions usually can be diagnosed by an examination by a physician. It is not unusual for a physician to recommend a mammogram, ultrasound, or biopsy procedure to assist or confirm the diagnosis (National Cancer Institute 2000b).
A mammogram, the most frequently used diagnostic tool for breast lumps, is a type of x-ray examination. If the mammogram suggests that abnormal tissue is benign, follow the physician's recommendations and recheck the lump (in perhaps 4 to 6 months) (National Cancer Institute 2000b). If the mammogram is inconclusive or if it indicates the need for further examination, your physician may recommend a computer-aided diagnosis procedure using ultrasound. This additional diagnostic procedure is designed to improve identification of a potentially malignant lesion.
Ultrasound uses high-frequency waves to outline a part of the body and is useful to further evaluate possible abnormalities found during mammograms or physical examinations. Besides aspiration, ultrasound is the only way to determine if the lump is a fluid-filled cyst. Fluid-filled cysts have a distinctive appearance on an ultrasound screen.
Fine-needle aspiration biopsy (FNAB) is used if the physician is almost certain that the lump is a cyst. Aspiration is also used to extract a material from a lump for further analysis (National Cancer Institute 2001b). A very thin needle is inserted into the breast tissue as the doctor palpates the lump. The procedure is essentially painless because nerves are located primarily in the skin, not in the breast tissue itself. Ultrasound is used to guide the needle when a lump is difficult to palpate or is very small. FNAB has decreased the need for surgical biopsy.
Core-needle biopsy uses a needle larger than the type employed with FNAB. The procedure is performed in a physician's office with local anesthesia of the breast area to be biopsied. Core-needle biopsy removes a small cylinder of tissue for examination.
Stereotactic biopsy is a newer approach that relies on a three-dimensional x-ray to guide the needle biopsy of non-palpable mass (National Cancer Institute 2001b). The breast is x-rayed from two different angles and a computer plots the position of the suspicious area. Once the area is precisely identified, the radiologist uses a needle to biopsy the lesion.
Surgical biopsy may also be necessary to remove all or part of a lump for examination (National Cancer Institute 2001b). This procedure is done either in a physician's office or in an outpatient hospital facility under intravenous sedation or local anesthesia.
There are newer methods, such as vacuum-assisted biopsy, which remove even more tissue, but so far there is no universal agreement about when these procedures should be used, even though current studies show consistent reliable results (Fine 2001; Maganini et al. 2001; Ohsumi et al. 2001; Jackman et al. 2002; Perlet et al. 2002).
TREATING FIBROCYSTIC BREAST DISEASE
Although some physicians consider FBD to be more correctly termed a condition, its symptoms cause significant pain and discomfort for many women. Women who have FBD may find relief from any of several conventional and natural treatments. Some procedures (FNAB) for the conventional treatment of FBD can often be performed in a physician's office. Other procedures (such as a biopsy) are usually performed in an ambulatory or hospital surgical facility.
Breast cysts are relatively simple to treat. Simple breast cysts are aspirated by a physician with a needle and syringe (National Cancer Institute 2001b). A biopsy is often not necessary. Fluid aspirated from a cyst is rarely tested unless it is bloody or the woman is older than 55 years of age. Gross breast cysts that are benign disappear after aspiration. (However, a cancerous lump remains even after fluid is withdrawn.) Following imaging by mammography and ultrasonography, complex cysts require laboratory investigation usually beginning with fine needle aspiration and perhaps biopsy.
Intraductal Papilloma
In intraductal papilloma, the diseased ducts can be removed surgically if discharge becomes bothersome (National Cancer Institute 2001a; 2001b). The appearance of the breast is usually unchanged.
Mastitis
Mastitis or postpartum mastitis is an infection that is treated with antibiotics (Anon. 1998). Pus-filled abscesses may need to be drained or removed. Lactating women with mastitis should use a breast pump to prevent additional pooling of breast milk and discard the milk. Breast milk should not be used until the infection has responded to antibiotic treatment.
Mammary Duct Ectasia
Mammary duct ectasia is treated with antibiotics, warm compresses, and sometimes surgery (National Cancer Institute 2001b).
HORMONE AND DRUG THERAPY
The anterior pituitary gland secretes follicle-stimulating hormone (FSH) which in turn causes follicle cells in the ovaries to secrete estrogens. The anterior pituitary also secretes luteinizing hormone (LH) which causes the corpus luteum to secrete progesterone and a small amount of estrogens, including estradiol (E2). LH and FSH work together to bring about ovulation and menstruation. The corpus luteum produces progesterone for about 11 days (the luteal phase) after ovulation. About 3 days later, when levels of estrogen and progesterone are at their lowest, menstruation begins.
In an early study comparing women with normal breast tissue to women with benign breast disease, there was a significant imbalance of progesterone over estradiol during the luteal phase in women with benign breast disease (Sitruk-Ware et al. 1979). When the women were grouped according to the type of breast lesion, there was elevated or normal estradiol in women with adenosis tumors and increased nodularity of both breasts. Plasma progesterone was also consistently lower in all groups as compared to the normal women. The authors concluded: "From these results it may be postulated that an imbalance in the secretion of E2 and progesterone by the corpus luteum is a constant finding in women with benign breast disease" (Sitruk-Ware et al. 1979).
Oral Contraceptives
Sometimes physicians treat breast pain and swelling associated with FBD by prescribing oral contraceptives which tend to stabilize (or level out) hormone levels. Results of studies indicate that oral contraceptives have positive benefits by decreasing the symptoms of FBD, particularly in younger women (Mishell 1993; Rohan et al. 1999; Scott 1993).
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