Sharifipour Foruzan, Siahkal Shahla Faal, Bagherinia Marzieh
Clinical Research Development Center, Motazedi Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Department of Midwifery, Marand Branch, Islamic Azad University, Marand, Iran.
BMC Womens Health. 2025 Sep 2;25(1):421. doi: 10.1186/s12905-025-03991-x.
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.
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.
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.
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.
乳房疼痛是女性一生中某个阶段最常见的主诉，会对受此病症影响的个体的身心健康产生深远影响。本研究旨在系统评估维生素B6对乳房疼痛严重程度的影响。
本研究是一项干预性研究的荟萃分析，比较了维生素B6与安慰剂对患有乳房疼痛的健康女性的影响。文献检索涵盖了从开始到2024年11月发表的研究，在包括科学网、Embase、考克兰图书馆、Scopus、PubMed和谷歌学术在内的各种电子数据库中以英文和波斯文进行。乳房疼痛的严重程度被视为结局指标。与月经周期相关的乳房疼痛称为周期性乳房疼痛或周期性乳腺痛。使用Stata软件版本17和随机效应模型对数据进行分析。利用考克兰偏倚风险评估清单对所选文章的质量进行评估。
共审查了301项研究，N = 951名参与者（干预组：536名，对照组：415名），最终有三项研究纳入荟萃分析。这三项研究的综合分析表明，维生素B6组和安慰剂组在减轻疼痛强度方面没有差异（标准化均数差=-3.57，95%可信区间：-9.15至2.01；证据确定性极低），研究之间存在高度异质性（I² = 99.56%）。纳入研究的总体质量被评估为低。
这项荟萃分析未显示维生素B6对乳房疼痛严重程度有统计学上的显著影响。证据受到可用研究数量少、方法学质量低以及大量临床和统计异质性的限制。需要进一步设计良好的大规模随机对照试验，以可靠地确定维生素B6对乳房疼痛的疗效。国际前瞻性系统评价注册库编号CRD 42,024,613,796。
