Li Jinkun, Huang Xudong, Yuan Yifeng, Zhang Haixin, Zhou Hang, Xiong Wei, Li Yuyi, Zhang Zechen, Qie Fengqing, Mao Yingdelong, Liang Bocheng, Shi Xiaolin, Liu Kang
The Second School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
The Second Affiliated Hospital of Zhejiang Chinese Medical University (Xinhua Hospital of Zhejiang Province), Hangzhou, Zhejiang, China.
Front Pharmacol. 2024 Nov 18;15:1505926. doi: 10.3389/fphar.2024.1505926. eCollection 2024.
Epimedium total flavonoids (EF) have been recommended to be one of the effective components in Traditional Chinese Medicine (TCM) for the treatment of primary osteoporosis (POP) in China. Due to the lack of evidence-based medical evidence on the efficacy and safety of EF for the treatment of POP, the current systematic review and meta-analysis was carried out aimed at evaluating the curative effects and safety profile of EF treatment for POP in order to provide decision making references for clinical research.
The PubMed, Cochrane Library, EMBASE, Web of Science, CNKI, Wanfang, and VIP databases were searched from the date of inception to 11 August 2024. The outcomes of effectiveness and safety of included studies were collected to conduct meta-analysis or systematic review.
A total of 6 RCTs were included in this study, involving 838 participants. Overall, our results revealed that the experimental group (EG) had comparable results of efficacy to the control group (CG). The lumbar vertebra bone mineral density (BMD) was statistically different compared to the CG (MD = 0.03; 95% CI: 0.01, 0.04; = 0.0003), but the clinical significance deserved consideration because the 95% CI nearly crossed the invalid line. The femoral neck BMD was neither statistically different nor clinically different between two groups (MD = 0.00; 95% CI: 0.01, 0.02; = 0.67). The total complication rates were comparable among the two groups (RR = 0.68; 95% CI: 0.39, 1,19; = 0.18). The quality of the evidence of the present study was judged as moderate and low based on the GRADE analysis.
EF treatment exhibited good curative effects and safety. The result was comparable to the CG, including other Chinese patent medicines and calcium and vitamin D supplements. The EF treatment was proved to be a reliable alternative option for POP.
在中国,淫羊藿总黄酮(EF)被推荐为治疗原发性骨质疏松症(POP)的中药有效成分之一。由于缺乏关于EF治疗POP疗效和安全性的循证医学证据,开展了本次系统评价和荟萃分析,旨在评估EF治疗POP的疗效和安全性,以为临床研究提供决策参考。
检索PubMed、Cochrane图书馆、EMBASE、科学网、中国知网、万方和维普数据库,检索时间从建库至2024年8月11日。收集纳入研究的有效性和安全性结局,进行荟萃分析或系统评价。
本研究共纳入6项随机对照试验,涉及838名参与者。总体而言,我们的结果显示,试验组(EG)与对照组(CG)的疗效相当。与CG相比,腰椎骨密度(BMD)有统计学差异(MD = 0.03;95%CI:0.01,0.04;P = 0.0003),但由于95%CI几乎跨越无效线,其临床意义值得考虑。两组之间股骨颈BMD在统计学上无差异,临床意义上也无差异(MD = 0.00;95%CI:0.01,0.02;P = 0.67)。两组的总并发症发生率相当(RR = 0.68;95%CI:0.39,1.19;P = 0.18)。根据GRADE分析,本研究证据质量被判定为中等和低等。
EF治疗显示出良好的疗效和安全性。结果与CG相当,包括其他中成药以及钙和维生素D补充剂。EF治疗被证明是POP的可靠替代选择。