我们的研究表明,B族维生素对骨折发生率没有显著影响,骨矿物质密度,和骨转换标记。然而,B族维生素对骨密度和骨转换标志物的研究数据有限,需要更多的临床试验来得出足够的结论。
目的:本研究的目的是确定B族维生素(VB)(叶酸,B6和B12)对骨折发生率的补充,骨矿物质密度(BMD),和骨转换标志物(BTMs)。
方法:在PubMed中进行了全面搜索,MEDLINE,EMBASE,Cochrane数据库,和ClinicalTrials.gov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)评估随机误差的风险,使用Stata14进行敏感性和发表偏倚分析。
结果:提取并分析了来自14个RCT的34,700名患者的数据。结果表明,VB并没有显着降低骨折发生率(RR,1.06;95%CI,0.95-1.18;p=0.33;I2=40%)并且不影响腰椎和股骨颈的BMD。VBs对骨特异性碱性相(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;I2=0%)。TSA显示,由于所包含的样本数据数量很少,需要在更多的临床试验中证明,因此VBs对BMD和BTM的结果可能不足以得出足够的结论。VBs无法减少骨折发生率已被TSA充分证实。敏感性分析和发表偏倚评估证明我们的meta分析结果稳定可靠,没有显著的发表偏倚。
结论:来自RCT的现有证据不支持VBs可以有效影响骨质疏松性骨折风险,BMD,和BTM。
背景:PROSPERO注册号:CRD42023427508。
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.
OBJECTIVE: 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; I2 = 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; I2 = 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.
BACKGROUND: PROSPERO registration number: CRD42023427508.