Effectiveness and safety of Chinese traditional medicine Ulcer Ointment for skin ulcers: a systematic review and meta-analysis of randomized controlled trials

Introduction Ulcer Ointment (UO), a topical agent derived from traditional Chinese medicine, has been widely used for skin ulcers. This review evaluates its effectiveness and safety. Methods We systematically searched eight databases for randomized controlled trials (RCTs) focusing on UO for skin ulcers. Pooled mean difference (MD) and relative risks (RR) with 95% confidence intervals (CI) were calculated. Results Fourteen RCTs involving 978 participants with diabetic foot ulcers, venous leg ulcers, acutely infected ulcers, and pressure ulcers were included. Overall study quality was low. Compared with no intervention, UO was associated with a higher healing rate (RR = 2.24, 95% CI: 1.42–3.52, 2 RCTs, n = 140), reduced ulcer area, shorter healing time, lower pain scores, and elevated vascular endothelial growth factor (VEGF) levels. UO were more efficacious than standard topical drugs in healing rate (RR = 1.87, 95% CI: 1.49–2.34, 8 RCTs, n = 462), percentage reduction in ulcer area (RR = 17.82%, 95% CI: 12.63–23.00, 3 RCTs, n = 179), ulcer area (RR = −1.66 cm 2 , 95% CI: −1.98 to −1.35, 3 RCTs, n = 157), healing time, clinical effective rate (RR = 1.21, 95% CI: 1.10–1.32, 9 RCTs, n = 491), TCM symptom complex scores, pain scores, and VEGF levels. Although these differences are statistically significant, the clinical reliability of these benefits remain uncertain. No severe adverse events were reported in the UO group. Conclusion Based on the currently available low-quality evidence, UO has shown preliminary indications of potential benefits in ulcer healing, improvement of TCM symptoms, pain alleviation, and elevation of VEGF levels. However, the exact efficacy of UO for skin ulcers requires further validation through high-quality double-blind RCTs.