Objective To provide evidence for clinical practice by assessing the effectiveness and safety of Ligustrazine for primary nephrotic syndrome. Methods We searched MEDLINE (1966.1-2002.12), EMBASE (1975-2002.12), CBM (1979.1-2002.12), Chinese Evidence-Based Medicine/Cochrane Centre Database (CEBM/CCD, Issue 4, 2002) , Cochrane Library, and SCI (1985-2002.12) and handsearched 15 kinds of journals (including Journal of Nephrology et al) (1980-2003.2) for the randomized controlled trials (RCTs).Jadad score was used to assess the quality of RCTs. The outcomes of short term and long term effectiveness, and adverse effect of the treatment were analyzed by RevMan 4.1. Results Thirteen RCTs involving 675 patients met inclusion criteria. Jadad scores of each trial was 1 point. Meta-analysis of 4 studies showed that Ligustrazine had significant better short term effect [OR 4.24, 95% confidence interval (CI) 1.76 to 10.19], lowered 24 h urine protein (OR -0.36, 95% CI -0.71 to -0.02), improved renal function [ creatinine level in children group: (OR -3.34, 95% CI -5.25 to -1.43), creatinine level in adult group: (OR -48.29, 95% CI -68.24 to -28.35)], and increased serum albumin level (OR 3.61, 95% CI 2.61 to 4.61). Whether Ligustrazine had long term side effect was not confirmed. No adequate evidence showed that Ligustrazine could reduce the relapse rate of primary nephrotic syndrome. Conclusions Meta-analysis of low quality RCTs suggest that Ligustrazine does work in primary nephritic syndrome in short term observation. No adequate evidence shows that Ligustrazine has severe side effect or can reduce the relapse rate of primary nephrotic syndrome. We can’t draw a conclusion that Ligustrazine is safe in primary nephrotic syndrome treatment.A rigorously designed, randomized, double blind, placebo controlled trial are required.