Omega-3 Fatty Acids plus Vitamin E Cosupplementation versus Vitamin E in Fibrocystic Breast Patient with Mastalgia: A Randomized Controlled Trial

BACKGROUND: Fibrocystic changes (FCCs) of the breast are a common breast condition. Mastalgia is the most common symptom of FCC; it usually causes fear of breast cancer and has negative effects on the quality of life. AIM: The objective of the research was to establish the effect of cosupplementation of omega-3 plus Vitamin E on mastalgia in FCC patients, to evaluate its effect with that of Vitamin E only, and to determine the effect of omega-3 plus Vitamin E versus Vitamin E only on the radiological findings in FCC patients. METHODS: This randomized controlled trial was conducted on 120 FCC patients with mastalgia. The participants were randomly assigned into three groups: Omega-3 plus Vitamin E group, Vitamin E only group, and control group. The new breast pain chart was used to assess the severity of mastalgia in the three groups before, through, and after intervention. Radiological assessment was done before and after the intervention. RESULTS: After 3 months of the intervention, there was a statistically significant difference between the three groups regarding radiological results with p > 0.05 and, after the 3rd month of interventions, there was a statistically significant difference between the groups regarding the new pain score with p > 0.001. The median of the new pain score premenstrual was 4.8, 2, and 2.5 in control, omega-3 plus Vitamin E, and Vitamin E only, respectively, but this difference was insignificant between the last two groups (p < 0.996). CONCLUSION: This study showed that Vitamin E and Vitamin E plus omega-3 were effective in relieving mastalgia in FCC patients. However, the addition of omega-3 was ineffective.