Erxian decoction for postmenopausal osteoporosis: An updated systematic review and meta-analysis.

BACKGROUND

Postmenopausal osteoporosis (PMO), a major cause of fractures and disability, places a burden on healthcare systems. Erxian Decoction (EXD), a traditional Chinese herbal formula, is commonly used to support bone health. However, its efficacy and safety in treating PMO remain uncertain. This study assessed the efficacy and safety of EXD combined with conventional treatments in PMO.

METHODOLOGY: Following PRISMA guidelines, we systematically searched MEDLINE, Embase, CENTRAL, CNKI, Wanfang, SinoMed, and Chongqing VIP database through July 2025 for randomized controlled trials (RCTs). Two reviewers independently conducted study selection, data extraction, and risk-of-bias assessment (RoB 2). Random-effects meta-analyses were performed using mean differences (MDs), odds ratios (ORs), relative risks (RRs), and 95 % confidence intervals (CIs).

RESULTS

Thirteen RCTs comprising 1,269 women were included. All studies were conducted in China and published between 2012 and 2025. EXD significantly improved lumbar spine bone mineral density (BMD) (MDs 0.05 g/cm² and 0.09 g/cm² in pharmacological and calcium-vitamin D settings), femoral neck BMD (MD 0.06 g/cm² in both settings), and pain intensity (VAS MDs -1.17 and -0.88). Biochemical outcomes showed improvements in CTX within pharmacological settings, and in serum calcium, BGP, and E2 within calcium-vitamin D settings. Clinical response showed consistent improvements (ORs 3.62 and 3.56). Adverse events were reported in five studies. Pooled analyses suggested fewer events with EXD (RR = 0.68), with statistical significance in one trial. Fracture incidence (reported in one study) favored EXD but was not statistically significant. Heterogeneity was substantial across outcomes but was partly reduced in sensitivity analyses after excluding studies at high risk-of-bias.

CONCLUSION

EXD combined with conventional therapy may improve BMD, reduce pain in patients with PMO, though the evidence regarding safety remains insufficient to draw firm conclusions. However, the current evidence is limited to small, single-country RCTs with methodological limitations. Confirmation requires larger, rigorously designed trials across diverse populations.