Effect of Yinhuangsan (YHS) on Diabetic Foot Ulcers (DFU): A Systematic Review and Meta-Analysis

Objectives: To assess the safety and effectiveness of Yinhuangsan (YHS) in patients with diabetic foot ulcers (DFU). Search Methods: Studies were selected from PubMed (1966 to January 2021), the Excerpta Medica Database (EMBASE) (1974 to January 2021), the Cochrane Library (1988 to January 2021), SinoMed (CBM) (1978 to January 2021), China Science and Technology Journal Data-base (VIP) (1994 to January 2021), Wanfang Data Knowl-edge Service Platform (1998 to January 2021) and the China National Knowledge Infrastructure (CNKI) (1984 to January 2021). No language restrictions were applied. Studies were identified and selected, and the data were extracted independently by two reviewers. The Cochrane Risk of Bias tool was used to assess the quality of studies. Revman 5.3 software was used for data synthesis and analysis. Results: Two studies were included based on the selection criteria. Two trials were of unsatisfied methodological quality and adopting different criteria to judge outcomes. As such, we were unable to perform a summary meta-analysis but concentrated on a narrative summary of results. Both the included studies had a low risk of incomplete data bias and selective reporting bias, while neither of them mentioned allocation concealment and blinding. Both two trials showed positive results favoring YHS compared with positive controls independently in total effective rate. One reported amputation rate, mortality and ulcer area change, and the other described ulcer healing rate. Neither of the trials stated adverse reactions and quality of life. Conclusions: There is currently inadequate evidence on evaluating YHS for DFU effectively, due to the paucity of randomized controlled trials and the low methodological quality in included studies. The safety of YHS remains unknown for lack of ample data on adverse events. Hence, YHS should be applied with caution. More high quality randomized controlled trials (RCTs) expected to strengthen the evidence for the effectiveness and safety of YHS treating DFU are in demand. Standardized monitoring or a valid reporting system should be adopted to critically estimate adverse events and the safety in the future.