Efficacy of Huangbai liniment for diabetic foot ulcers with multidrug-resistant organism infection: a randomized controlled multicenter trial

Background Diabetic foot infection, particularly with multidrug-resistant organisms (MDROs), is a serious complication of diabetic foot ulcers (DFUs) that increases wound healing time and amputation risk. Prolonged use of broad-spectrum antibiotics can contribute to antibiotic resistance and limit future treatment options. Developing effective non-antibiotic antibacterial therapies is therefore urgently needed. Huangbai liniment (HB) is a standardized herbal product clinically used to treat diabetic foot infections, including methicillin-resistant Staphylococcus aureusStaphylococcus aureus (MRSA). This trial assessed the efficacy and safety of HB for DFUs with mild MDRO infection. Methods This multicenter, open-label, randomized controlled trial was conducted in China. A total of 154 patients with DFUs and mild MDRO infection were randomly assigned to the HB group and the silver dressing (SD) group. Both groups received the same basic treatment for diabetic foot disease. The HB group received Tazi therapy (topical application of HB) for 2 weeks, while the control group was treated with SD. Primary outcome was the resolution of infection defined as a change from mild infection to no infection (using the Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections). Secondary outcomes included the MDRO conversion rate, rate of completing ulcer healing, and reduction in ulcer size. Results A total of 74 patients in the HB group and 63 patients in the SD group were included. Infection was resolved in 35 patients (47.3%) in the HB group versus 13 patients (20.6%) in the SD group ( p = 0.001). Mixed-level logistic regression analyses showed that the HB group was associated with resolution of infection [odds ratio (OR) = 4.81; 95% confidence interval (CI): 2.01–12.48; p < 0.001]. However, there was no difference in rate of completing ulcer healing and reduction of ulcer size. Conclusion Topical HB effectively facilitated mild infection resolution and MDRO conversion, with no adverse effects. HB is an effective and safe adjunctive therapy for short-term infection resolution in patients with DFU with mild MDRO infection. However, no evidence emerged for improved ulcer healing within 2 weeks. Longer follow-up is needed to assess wound healing outcomes. Clinical trial registration https://www.chictr.org.cn/showproj.html?proj=66175 ., identifier ChiCTR2000041443.