Fibrocystic breast change (FBC), aka fibrocystic breast disease (FBD) is a benign disorder of the breasts that can result in lumpiness, nodules and/or pain. It is not associated with breast cancer risk, but it makes it hard to decipher if a nodule is benign or cancerous because it is not easy to distinguish these lumps from solid tumors that might be malignant. Conventional treatments include nonsteroidal anti-inflammatory drugs (NSAIDS) and in severe cases, even some strong hormonal medications.
Historically, there have been studies of evening primrose oil or various forms of iodine to reduce breast pain that have showed benefit, but some doses of iodine that lead to relief, exceed recommended safety limits. The current study was a multicenter, prospective, randomized, double-blind, controlled parallel-group study in the United Kingdom. Women were randomized to receive a liquid formulation that contained 1 gm of gamma-linolenic acid (GLA), 50 mcg of iodine and 70 mcg of selenium, or the received the liquid formula without the GLA, iodine or selenium. They were given 4 oz of the liquid formula daily for three menstrual cycles. Breast pain, medications and menstrual signs were recorded and nodularity of the breasts was determined with a clinician exam.
Breast pain scores decreased similarly in both groups, by about 30%. Nodularity was reduced in the treatment group but not the control group and the amount of pain medication was reduced in the treatment group relative to the control group. The amount of nodularity reduction was 53% in the number of women with the most severe breast nodularity where breast pain was the most severe. 
Commentary: The strengths of this study lie in the combination of the GLA and the iodine, both known to reduce mastalgia. This study showed the strongest benefit in reducing nodularity, a condition associated with less cyclic breast pain. In addition, women who were in the treatment group used less pain medications over time, to manage their breast pain. The strongest studies prior to this, for cyclic mastalgia include those with chaste tree berry, evening primrose oil, vitamin E, and iodine. It is important to be very cautious with iodine, as over 1100 mcg/day is considered above the tolerable upper limit of safety.
Reduce Breast Density to Reduce Breast Cancer Risk
Breast density status is now typically reported on the screening mammogram report and approximately 50% of women who undergo screening mammography have either heterogeneously or extremely dense breast tissue. Dense breast tissue is defined as a greater amount of fibrous or glandular tissue than fatty tissue in the breasts. Women with dense breast tissue have a modestly elevated risk for breast cancer and the sensitivity of screening mammography is reduced by dense breasts.
One of the goals of natural medicine is to reduce the risk for chronic disease, and if someone has extremely dense breasts on mammography, and/or a first degree relative with breast cancer, I recommend strategies that might reduce breast density, and thus reduce the risk of breast cancer. One of those strategies is N-acetylcysteine (NAC). A 2012 study included 25 postmenopausal women randomized to receive either 1 – 1.5 g metformin or 400 – 600 mg of NAC over an average of 10 months. Mammographic breast density was measured before and after completion of the study. Both groups exhibited reductions in mammographic breast density. The metformin group had a 28.5% reduction and the NAC group a 27.3% reduction.
Commentary: While this is a small study NAC supplementation may represent a useful strategy to reduce breast cancer risk in those who are above average risk of breast cancer.
Do Oral Contraceptives Affect Risk for Breast Cancer?
The issue of whether or not oral birth control pills increase the risk of breast cancer or not, has been confusing and contradictory for at least the last 20 years. It is certainly an ongoing concern in the minds of many women and clinicians. This recent prospective cohort study from the Denmark national data base attempted to determine if there was any association between use of hormonal contraception and risk for invasive breast cancer in women aged 15-49. Approximately 1.8 million women were followed for an average of 10.9 years from 1995-2012. In that period of time, 11,517 breast cancers were diagnosed. Most of the hormonal contraceptives were oral formulations and then secondarily, progestin IUDs. The relative risk for breast cancer in current or recent users of these products was compared to those women who never used hormonal contraception and found to be 1.20 with an absolute risk of 13 additional cases of breast cancer per 100,000 person years. Current or recent use of the progestin IUD was associated with a similar, 1.21 relative risk. Breast cancer was uncommon in women who used contraceptive implants or injections.
Commentary: While the authors of this study adjusted the findings for many things, including duration of hormonal contraceptive use, age, education, parity, polycystic ovary syndrome, endometriosis and a family history of breast or ovarian cancer. What they did not adjust for was clinical breast examinations, screening mammograms and lactation history, all of which are considered potential issues that confound the results. In addition, it must be factored in that > 80% of breast cancers are in women older than 49, and in the current analysis, they limited their aged group to women between 15 and 49.
Researchers consider that a relative risk of less than 2 or 3 should not be interpreted as an indication of causation; so in this study, with the results of 1.21, it could not be concluded that current or recent use of hormonal contraception was the cause of their breast cancer. In one of the definitive studies on this topic, conducted by the Centers for Disease Control and published in the New England J of Medicine in 2002, there was no suggestion of an excess risk for breast cancer with use of oral contraceptives. [3, 4]
The current study does indicate the possibility of a very small increase in risk, the best available data on this topic does shows that they do not have an impact on the risk of breast cancer. With increased understanding of numerous genes, on breast cancer risk, not just BRCA genes, and an increased attention to the effect of environmental pollutants, it is likely that this is where we should be putting our attention. However, it may also be true that in women who take in particular oral contraceptives, these medications may provide some kind of fertile environment for then an added negative influence from the genetic issues as well as environmental exposures, two areas that currently leave us asking more questions. In the meantime, there are numerous non hormonal options for contraception, and pregnancy is a risky enterprise in and of itself, with medical risks that outpace the POSSIBLE very small increase relative risk of birth control pills and breast cancer.
And don’t forget… there is good published scientific evidence that the following reduce our risk of breast cancer: exercise at least 3.5 hours per week; less alcohol- not more than 7 drinks/week (some data says 0-3/week), avoid overweight/obesity; while the research is not as robust, there is also evidence that we can reduce our risk of breast cancer by eating a Mediterranean diet, getting more sunshine (adequate vitamin D levels), fish and/or fish oil supplements, higher fiber diets, olive oil, and green tea.
1) Mansel, R., et al. J Women’s Health 2018 27(3):333-340.
2) Bershtein., L.M, et al. Vopr Onkol. 2012;58(1):45-49.
3) Morch, L., et al. NEJM 2017;7; 377:2228
4) Hunter, D. NEJM 2017;7;377:2276