Clinical Efficacy of Traditional Chinese Medicine Soaking Treatment for Diabetic Foot Ulcer: A Meta-analysis and Sequential Analysis
WANG Xue-wan，WANG Ning，ZHOU Tong
Abstract:
Objective To conduct a Meta-analysis to evaluate the clinical efficacy of traditional Chinese medicine soaking treatment for diabetic foot ulcer (DFU). Methods Databases including PubMed, Cochrane Library, CNKI, Wanfang and VIP data were searched to collect randomized controlled trials (RCTs) about traditional Chinese medicine soaking in the treatment of DFU from inception to September 1st, 2021.The Cochrane risk assessment of bias was used to evaluate the methodological quality of the literature, and RevMan5.3 software was used for Meta analysis. Experimental sequential analysis of outcome indicators using TSA 0.9 software. Results A total of 16 RCTs involving 1 404 patients were included.The result of Meta-analysis showed that clinical effectiveness of traditional Chinese medicine soaking was significantly higher than that of the control group in DFU [RR=1.22，95%CI (1.12,1.33)].The trial sequential score showed that the cumulative Z value for the effective rate crossed the TSA cut-off in test 3. The evidence for the treatment of diabetic foot ulcers by Chinese herbal medicine (TCM) with sweat stain was conclusive and the conclusion could exclude the possibility of a false positive. Conclusion Traditional Chinese medicine soaking method is an effective and safe method for the treatment of diabetic foot ulcer, however, there is publication bias as well as no high-quality research, so high-quality large-sample multicenter randomized controlled trials should be carried out.
