B 族维生素与骨骼健康：一项随机对照试验的荟萃分析与试验序贯分析。
B vitamins and bone health: a meta-analysis with trial sequential analysis of randomized controlled trials.
机构信息
Department of Orthopedics, Xiangya Hospital, Central South University, Changsha, Hunan, China.
National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.
出版信息
Osteoporos Int. 2024 Sep;35(9):1645-1659. doi: 10.1007/s00198-024-07150-0. Epub 2024 Jul 2.
UNLABELLED
Our study showed that B vitamins did not have significant effect on fracture incidence, bone mineral density, and bone turnover markers. However, the research data of B vitamins on bone mineral density and bone turnover markers are limited, and more clinical trials are needed to draw sufficient conclusions.
PURPOSE
The objective of this study was to identify the efficacy of B vitamin (VB) (folate, B6, and B12) supplements on fracture incidence, bone mineral density (BMD), and bone turnover markers (BTMs).
METHODS
A comprehensive search was performed in PubMed, MEDLINE, EMBASE, Cochrane databases, and ClinicalTrials.gov up to September 4, 2023. The risk of bias was assessed according to Cochrane Handbook and the quality of evidence was assessed according to the GRADE system. We used trial sequential analysis (TSA) to assess risk of random errors and Stata 14 to conduct sensitivity and publication bias analyses.
RESULTS
Data from 14 RCTs with 34,700 patients were extracted and analyzed. The results showed that VBs did not significantly reduce the fracture incidence (RR, 1.06; 95% CI, 0.95 - 1.18; p = 0.33; I = 40%) and did not affect BMD in lumbar spine and femur neck. VBs had no significant effect on bone specific alkaline phase (a biomarker for bone formation), but could increase the serum carboxy-terminal peptide (a biomarker for bone resorption) (p = 0.009; I = 0%). The TSA showed the results of VBs on BMD and BTMs may not be enough to draw sufficient conclusions due to the small number of sample data included and needed to be demonstrated in more clinical trials. The inability of VBs to reduce fracture incidence has been verified by TSA as sufficient. Sensitivity analysis and publication bias assessment proved that our meta-analysis results were stable and reliable, with no significant publication bias.
CONCLUSIONS
Available evidence from RCTs does not support VBs can effectively influence osteoporotic fracture risk, BMD, and BTMs.
TRIAL REGISTRATION
PROSPERO registration number: CRD42023427508.
目的
本研究旨在确定 B 族维生素（叶酸、B6 和 B12）补充剂对骨折发生率、骨密度（BMD）和骨转换标志物（BTM）的疗效。
方法
我们在 PubMed、MEDLINE、EMBASE、Cochrane 数据库和 ClinicalTrials.gov 上进行了全面检索，检索截至 2023 年 9 月 4 日。根据 Cochrane 手册评估偏倚风险，并根据 GRADE 系统评估证据质量。我们使用试验序贯分析（TSA）评估随机误差风险，并使用 Stata 14 进行敏感性和发表偏倚分析。
结果
共提取和分析了来自 14 项 RCT 的数据，涉及 34700 名患者。结果表明，B 族维生素不能显著降低骨折发生率（RR，1.06；95%CI，0.95-1.18；p=0.33；I=40%），也不能影响腰椎和股骨颈的 BMD。B 族维生素对骨碱性磷酸酶（骨形成的生物标志物）没有显著影响，但可以增加血清羧基末端肽（骨吸收的生物标志物）（p=0.009；I=0%）。TSA 显示，由于纳入的样本数据较少，VBs 对 BMD 和 BTM 的影响结果可能不足以得出充分的结论，需要在更多的临床试验中证明。TSA 也验证了 B 族维生素不能降低骨折发生率的结论是充分的。敏感性分析和发表偏倚评估证明，我们的荟萃分析结果稳定可靠，不存在显著的发表偏倚。
结论
来自 RCT 的现有证据不支持 B 族维生素能有效影响骨质疏松性骨折风险、BMD 和 BTM。
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