Abstract
Objective: A randomized, multicenter, controlled double-blind trial was performed in women with cyclic breast pain (mastalgia) associated with fibrocystic breast changes (FBCs) to determine whether a nutritional formula reduced breast pain and/or nodularity.Study Design: Women were randomized to receive a specifically designed liquid formulation (n = 93) (1 g gamma-linolenic acid [GLA], 750 μg iodine, and 70 μg selenium) or control formula (n = 95) (without GLA, iodine, and selenium) daily for three cycles. Women recorded breast pain, medications, and menstrual signs daily using interactive voice-response system. Nodularity was determined by physical breast examination.Results: Breast pain scores decreased similarly in the experimental (−32.2%) and control (−33.1%) groups (p = 0.64). Nodularity was reduced in the experimental, but not the control group (p = 0.03). Among women who continued pain medication, the amount was reduced in the experimental group relative to controls (p = 0.02).Conclusion: Women with FBC using the formula containing GLA, iodine, and selenium experienced reduced nodularity and in those women who took over-the-counter breast pain medication, a decrease in the quantity of pain medication was observed.
Highlights
Fibrocystic breast change (FBC) is a benign disorder of breast physiology that can result in lumpiness or nodule formation
A randomized, multicenter, controlled double-blind trial was performed in women with cyclic breast pain associated with fibrocystic breast changes (FBCs) to determine whether a nutritional formula reduced breast pain and/or nodularity
The randomized controlled study evaluated the effect of a novel nutritional formula containing a combination of gamma-linolenic acid (GLA), iodine, and selenium to reduce cyclic breast pain and nodularity in women with FBC
Summary
Fibrocystic breast change (FBC) is a benign disorder of breast physiology that can result in lumpiness or nodule formation. The prevalence of breast nodularity in a random population-based sample of women in the community and hospital is 62%.1. In FBC, breast nodularity is due to small breast masses (fibrosis) and breast cysts. Nodularity does not increase breast cancer risk, but it can make a mammogram more difficult to read or interpret. Cysts are palpable as discrete, rounded lumps, which cannot be reliably distinguished from solid tumors. Fibrosis is composed of fibrous and epithelial tissue and present as firm, nontender, palpable lumps.
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