Effectiveness and safety of Astragalus membranaceus-based traditional Chinese medicine in treating diabetic foot ulcers: A systematic review and meta-analysis of randomized controlled trials

• Systematic review of 44 trials on Astragalus membranaceus for diabetic foot ulcers. • Astragalus membranaceus-based prescriptions enhanced diabetic foot ulcer healing. • Potential benefits identified but require high-quality trials to confirm efficacy. Astragalus membranaceus (AM) is a traditional Chinese medicine employed for supplementing qi and was particularly used for ulcer treatment. This systematic review aimed to examine the effectiveness and safety of AM-based prescriptions (AMPs) for diabetic foot ulcer (DFU). We searched eight databases to identify randomized controlled trials (RCTs) focusing on AMPs for DFU. The mean difference (MD) and relative risk (RR) with 95% confidence interval (CI) were calculated and used in the meta-analysis. We included 44 RCTs involving 3,238 participants. The AMPs included 24 oral AM formulas, 14 topical AM formulas, 4 topical AM alone, and 2 injections. Overall, study quality was low. Compared with Western medicine (WM), AMPs were associated with a higher healing rate (RR 1.64, 95% CI 1.4 to 1.9, 8 RCTs, n = 747), smaller ulcer size (MD –12.11 cm 2 , 95% CI –19.23 to –4.99, 4 RCTs, n = 304) and shorter healing time (MD –7.82 days, 95% CI –10.59 to –5.05, 4 RCTs, n = 353). AMPs plus WM were more efficacious than WM in healing rate (RR 1.22, 95% CI 1.07 to 1.4, 20 RCTs, n = 1497), amputation rate (RR 0.42, 95% CI 0.27 to 0.66, 3 RCTs, n = 265), mortality (RR 0.29, 95% CI 0.12 to 0.71, 3 RCTs, n = 265), ulcer size (MD –1.78 cm 2 , 95% CI –2.55 to –1.01, 10 RCTs, n = 761), healing time, ankle-brachial index (ABI), pain scores, clinical effective rate, and general symptoms. No severe adverse events were reported in the AMPs group. AMPs may have potential effectiveness in ulcer healing, ABI increase, and pain alleviation. The exact efficacy of AMPs for DFU needs to be confirmed using high-quality double-blind RCTs. Protocol of this review was registered via PROSPERO (CRD42024613403). National Science and Technology Major Project of China [grant number 2017ZX09304019].