The effectiveness of vitamin B6 in reducing mastalgia: a systematic review and meta-analysis.

Background: Mastalgia represents the most frequent complaint among women at some point during their lives that can have a profound impact on both the physical and mental well-being of individuals affected by this condition. This study aims to systematically evaluate the effect of vitamin B6 on the severity of mastalgia.

Design: This study is a meta-analysis of interventional studies that compare the effects of vitamin B6 to a placebo in healthy women with Mastalgia. The literature search encompassed studies published from inception until November 2024 and was conducted across various electronic databases, including Web of Science, Embase, Cochrane Library, Scopus, PubMed, and Google Scholar, in both English and Persian languages. The severity of breast pain was considered as the outcome measure. Breast pain linked to the menstrual cycle is called cyclic breast pain or cyclic mastalgia. The data were analyzed using Stata software version 17 and a random effects model. The quality of the selected articles was assessed utilizing the Cochrane Risk of Bias assessment checklist.

Results: A total of 301 studies with N = 951 participants (intervention:536, control: 415) were reviewed, with three studies ultimately included in the meta-analysis. The combined analysis of these three studies indicated that there were no differences between the two groups of vitamins B6 and placebo in a reduction of pain intensity (SMD = -3.57, 95% CI: -9.15 to 2.01; very low certainty of evidence), with high heterogeneity among the studies (I² = 99.56%). The overall quality of the included studies was assessed to be low.

Conclusion: This meta-analysis did not demonstrate a statistically significant effect of vitamin B6 on mastalgia severity. The evidence is limited by the small number of available studies, low methodological quality, and substantial clinical and statistical heterogeneity. Further well-designed, large-scale randomized controlled trials are needed to reliably determine the efficacy of vitamin B6 for mastalgia. PROSPERO CRD 42,024,613,796.