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Background. Diabetic nephropathy (DN) is a major cause of end-stage renal disease. In order to palliate renal function impairment and reduce kidney related mortality, it is crucial to treating DN patients at the early stage. This study aims to assess the efficacy and safety of conventional therapy combined with safflower yellow versus conventional therapy alone in early DN patients. Methods. A meta-analysis of randomized controlled trials that compared safflower yellow plus conventional therapy with conventional therapy alone in early DN patients was conducted. Papers were searched using the electronic databases and reference lists. Two reviewers working independently extracted relevant data and carried out risk-of-bias assessments. Statistical analysis was undertaken in Review Manager 5.3. Results. Fourteen trials (1,072 patients) were included in the meta-analysis. Conventional therapy combined with safflower yellow was associated with a higher effective rate (RD, 0.24; 95% CI, 0.17 to 0.30) and a greater decline in urinary albumin excretion rates (SMD, -1.34; 95% CI, -1.77 to -0.92), fasting blood glucose (MD, -0.57; 95% CI, -0.98 to -0.16), serum creatinine (MD, -12.36; 95% CI, -14.66 to -10.06), and blood urea nitrogen (SMD, -0.93; 95% CI, -1.13 to -0.73) in the subgroup with a follow-up time > 15 days. The incidence of adverse events did not differ significantly between these two regimens (RD, -0.01; 95% CI, -0.03 to 0.01). Findings were similar in the subgroup with a follow-up time < 15 days. Conclusions. Conventional therapy combined with safflower yellow had a more beneficial effect than conventional therapy alone in early DN patients. There were significant differences in effective rate, urinary albumin excretion rates, fasting blood glucose, serum creatinine, and blood urea nitrogen between the two regimens and no significant difference in adverse events. More randomized controlled research using standardized protocols would be needed in the future to compare these two regimens. [ABSTRACT FROM AUTHOR]