Clinical effectiveness of vitamin E and vitamin B6 for improving pain severity in cyclic mastalgia

BACKGROUND: Recent attempts have been focused on employing chemical and natural supplemental agents for treatment of cyclic mastalgia. Among various agents, the potential effects of vitamins remain questionable. In the present study, we examined the efficacy of two types of these vitamin supplements (vitamin E and vitamin B6) in improving pain severity in cyclic mastalgia. MATERIALS AND METHODS: In a randomized double-blinded clinical trial, 80 patients suffering from cyclic mastalgia were randomly assigned to receive 200 IU of vitamin E daily or 40 mg/day of vitamin B6 for 2 months. Written informed consent was obtained from all participants. Severity of breast pain was detected by the Cardiff breast pain score during one menstrual cycle before and two menstrual cycles after the intervention. Data were analyzed using t-test, Chi-squared test, analysis of variance (ANOVA), and regression with SPSS version 19 and P < 0.05 was considered significant. RESULTS: There was no significant difference in the mean of severity of cyclic mastalgia during one menstrual cycle before the intervention between the vitamin E and B6 groups (9.1 ± 2.1 and 8.4 ± 3.1, respectively), but the difference was significant during the first cycle (5.1 ± 1.6 and 5.2 ± 2.5, respectively) and the second menstrual cycle (2.3 ± 1.0 and 2.6 ± 2.0, respectively) in the two groups after the intervention. The trend of changes in pain severity score showed significant downward trend of pain severity score within the study period in both the treatment groups (P < 0.001), while these trends were similar in both groups when examined by the repeated-measure ANOVA test. By multivariable linear regression analysis adjusted for baseline variables, we found that both the treatment regimens resulted in similar reduction in breast pain severity (P = 0.067). CONCLUSIONS: Both regimens containing vitamin E and vitamin B6 are similar in reducing breast pain severity in cyclic mastalgia.