Objectives: To compare therapeutic effects of placebo with intake of low doses of acetyl-salysilic acid (aspirin) and a compound of retinol, pyridoxine chlorhydrate and tocopherol acetate.
Methods: The study is a prospective, controlled, triple blinded, randomized trial. From 259 patients, 81 were selected in order to follow rigid criteria of inclusion. They were divided into three groups of 27 patients, taking aspirin, vitamins or placebo respectively. The number of patients in each group was considered satisfactory for statistical analysis. Pain was scored as Grade 1 (without pain), Grade II (moderate pain) and Grade III (severe pain). The Tukey test was applied for comparison of results (statistical significance 5%).
Results: Clinical parameters, age, weight, BMI, parity and lactation period were similar for each group. There was a decrease of pain intensity in all groups, that was even more pronounced for the placebo group.
Discussion: Emphasis was given to symptomatic treatment of cyclic premenstrual mastalgia with symptoms considered to be the expression of a physiological process that can be treated with simple drugs or placebo. Usual therapeutic approaches with several drugs are criticized, including results and contraindications.
Conclusion: This study based upon acceptable trial methodology (randomized, triple blinded, placebo controlled, prospective) did not show significant differences in the treatment of cyclic mastalgia.