RESUMO
BACKGROUND: Cyclical mastalgia, which is characterized by cyclic breast pain associated with the menstrual cycle, is a common condition among premenopausal women. Despite their prevalence, effective treatment options remain limited. Evening primrose oil (EPO) and vitamin E have been proposed as potential therapies for cyclical mastalgia; however, their efficacy remains uncertain, particularly when used in combination. OBJECTIVE: This study aimed to evaluate the efficacy of EPO, vitamin E, and their combination in alleviating breast pain associated with cyclical mastalgia through a randomized controlled trial. METHODS: Premenopausal women (n=126) with cyclical mastalgia were recruited from gynecology clinics and randomized to receive EPO (1000 mg twice daily), vitamin E (400 mg once daily), their combination, or a placebo for six months. Randomization was performed using computer-generated random numbers. Participants were assessed at baseline and monthly intervals for six months. The primary outcome was the change in breast pain severity measured using a validated pain questionnaire such as the short-form McGill Pain Questionnaire. The secondary outcomes included changes in breast pain characteristics, adverse effects, and treatment adherence. RESULTS: A total of 126 participants participated in this study. The combination of EPO and vitamin E demonstrated superior efficacy in reducing breast pain severity compared with individual treatments and placebo (p < 0.001). Participants in the combination group experienced a mean reduction in breast pain severity of 4.5 points on the pain scale, whereas those in the EPO and vitamin E groups experienced reductions of 2.5 and 3.0 points, respectively. Both EPO and vitamin E alone also showed significant improvements compared with placebo (p < 0.05), with mean reductions in breast pain severity of 2.0 and 2.5 points, respectively. Adverse effects were minimal and comparable across the treatment groups. CONCLUSION: Combination therapy with EPO and vitamin E appears to be an effective treatment option for cyclical mastalgia, offering superior pain relief compared with individual treatments and placebo.
