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Randomised trial, 2006

Does aspirin or vitamins help with cyclic breast pain before your period?

No, neither aspirin nor a vitamin combination worked better than placebo. The placebo group actually improved the most.

Moderate study design 81 women with cyclic premenstrual breast pain

What they did

81 women with cyclic breast pain were randomly divided into three equal groups of 27. One group took aspirin, one took a vitamin combination, and one took placebo. Symptom severity was rated as none, moderate, or severe.

What they found

Pain decreased in all three groups. The placebo group had the most pronounced decrease. There were no statistically significant differences in pain reduction between the three groups.

What it means for you

Neither treatment beat placebo, suggesting they may not work for cyclic breast pain. The strong placebo response is notable. Only 81 of 259 screened women met strict inclusion criteria.

81

women studied

27

women per treatment group

3

treatment cycles

About the study

Original title
[Pre-menstrual cyclic mastalgia]
Authors
De Luca LA, Gonçalves Mde F, de Carvalho LR
Journal
Revista da Associacao Medica Brasileira (1992)
Year
2006
Study design
Randomised trial
Participants
259
What was tested
Low-dose aspirin or vitamin combination (retinol, pyridoxine, tocopherol) versus placebo
Open access
Yes
Original abstract

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.

Reproduced under CC-BY.

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