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 does make 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 they 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.
Reference: Mansel R, Das T, Baggs G, et al. A randomized controlled multicenter trial of an investigational liquid nutritional formula in women with cyclic breast pain associated with fibrocystic breast changes. J Women’s Health 2018 27(3):333-340.
