Abstract
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. 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. 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. 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. 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.
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