Effectiveness and Safety of Chinese Traditional Medicine Ulcer Ointment for Skin Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Summary: Published March 12, 2026 in Frontiers in Pharmacology (Ethnopharmacology section), this systematic review and meta-analysis from Dongzhimen Hospital, Beijing University of Chinese Medicine — registered on PROSPERO (CRD420251177748) and following PRISMA 2020 guidelines — evaluates the clinical effectiveness and safety of Ulcer Ointment (UO), a topical traditional Chinese medicine (TCM) agent with over 50 years of clinical use, standardized into a hospital-prepared proprietary medicine at Dongzhimen Hospital in 2005. UO is formulated from a 1:1:1 mixture of Rheum palmatum L. (rhubarb; clears heat, eliminates stasis), Angelica dahurica (drains pus, regenerates tissue), and Ligusticum chuanxiong (activates blood circulation), fried in sesame oil until brittle, then filtered and sterilised. The meta-analysis included 14 RCTs encompassing 978 adult patients with diabetic foot ulcers (8 RCTs), venous leg ulcers (4 RCTs), acutely infected ulcers (1 RCT), and diabetic foot or pressure ulcers (1 RCT). Compared with no intervention (2 RCTs, n=140), UO was associated with a higher healing rate (RR=2.24, 95% CI 1.42–3.52, I²=0%), reduced ulcer area, shorter healing time, lower pain scores, and elevated serum VEGF levels. Compared with standard topical biomedical agents (ethacridine lactate, rhEGF, metronidazole), sensitivity-adjusted meta-analysis after excluding a high-dropout-rate trial showed: healing rate RR=1.87 (95% CI 1.49–2.34, I²=0%; 8 RCTs, n=462); percentage reduction in ulcer area 17.82% improvement (CI 12.63–23.00; 3 RCTs, n=179); absolute ulcer area reduction −1.66 cm² (CI −1.98 to −1.35; 3 RCTs, n=157); healing time −8.30 days; and clinical effective rate RR=1.21 (95% CI 1.10–1.32; 9 RCTs, n=491). No severe adverse events were reported. However, the GRADE assessment rated the overall certainty of evidence as low to very low, and significant publication bias was detected for the clinical effective rate outcome. All studies were conducted in China, none were placebo-controlled, and the majority carried high risk of bias.
Key Highlights:
- 14 RCTs, 978 patients; wound types: DFU (8), VLU (4), acutely infected ulcer (1), DFU/pressure ulcer (1); all conducted in China, primarily at Dongzhimen Hospital; overall risk of bias high or some concerns
- vs. No intervention (n=140): healing rate RR=2.24 (I²=0%); ulcer area MD=−1.85 cm²; healing time MD=−3.00 days; pain SMD=−0.39; VEGF MD=+22.18 pg/mL — all statistically significant
- vs. Biomedicine (sensitivity-adjusted, n=462): healing rate RR=1.87 (I²=0%); ulcer area reduction −1.66 cm² (I²=0%); percentage reduction 17.82% (I²=0%); clinical effective rate RR=1.21 — all statistically significant after excluding high-dropout trial
- UO botanical composition: Rheum palmatum (anti-inflammatory, antibacterial); Angelica dahurica (pro-angiogenic, tissue regeneration); Ligusticum chuanxiong (blood circulation activation); sesame oil base creates physical barrier against bacterial invasion
- Safety: no severe adverse events; one mild pruritus event in each group (adhesive tape); no drug allergy, aggravated infection, or clinically significant laboratory abnormalities observed
- Limitations: low-to-very-low certainty evidence (GRADE); significant publication bias for clinical effective rate; all studies in China, no placebo control; standardised manufacturing protocols needed for broader clinical application
Keywords: traditional Chinese medicine skin ulcer, TCM wound healing topical, ulcer ointment diabetic foot, venous leg ulcer herbal treatment, Angelica dahurica wound healing, wound care meta-analysis 2026
Bingrui Zhang, Wenying Wang, Shengxian Wu, Baochen Zhu, Lei Chen, Fengtong Liu, Xiaoran Li, Dongyang Lin, Mingyue Liu, Xi Li