A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes

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) (1g gamma-linolenic acid [GLA], 750g iodine, and 70g 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.