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.
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
- Read the paper
- doi.org/10.1590/s0104-42302006000400029
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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