Danshen (Chinese Medicinal Herb) Preparations For Primary Nephrotic Syndrome:a Systematic Review Of Randomized Controlled Trials

BackgroundPrimary nephrotic syndrome (PNS) is a common, multiple of glomerular disease, is a common cause of chronic renal failure. Corticosteroids, alkylating agents (eg. CTX) and cyclosporine are primary medications which are used by modern medicine. While many of these are effective in the treatment of PNS, there are many associated side effects including infection, osteoporosis, suppression of bone marrow and liver damage after a longer term use.at the same time condition easily repeated in some patients after decreasing dosage or stopping medication. Part of patients tend to steroid dependence and resistance to the development of refractory nephrosis syndrome. Danshen preparations have been used to treat primary nephrotic syndrome (PNS) for years in China, however the effects and safety of these preparations have not been systematically reviewed.ObjectiveTo assess the benefits and harms of Danshen preparations in treating PNS in any age group, either as sole agents or in addition to other drug therapies.Materials and MethodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CNKI, VIP. There was no language restriction. Date of most recent search:Oct.2011. All randomised controlled trials (RCTs) assessing the use of Danshen preparations in treating PNS in adults and children, either as sole agents or in addition to other drug therapies. Two authors independently assessed study quality and extracted data. Methodological qualities of included studies were evaluated by the quality assessmentstandard of randomized controlled trials of Revman5.1.6and evidence qualities of outcomes were evaluated by GRADEprof iler3.6. Heterogeneity was assessed with chi-square statistics, if have the heterogeneity of statistics, used random effects mode, if not used fixed-effect mode. For dichotomous outcomes results were expressed as relative risk (RR) and95%confidence intervals (CI). Continuous outcomes results were expressed as mean difference (MD) with95%CI.ResultsOf2395articles identified,3were RCTs suitable for inclusion, which enrolled256patients. All compared Danshen preparations in addition to other drugs (steroids and/or CTX) versus other drugs (steroids and/or CTX) alone. Danshen preparations had a positive effect on no-improvement (RD=0.27,95%CI:0.09to0.77, P=0.01)、total urinary protein quantitation (MD1.45,95%Cl0.84to2.06, P<0.00001)、cholesterol (MD=2.18,95%Cl1.63to2.74, P<0.00001) and serum creatinine (MD=37.46,95%Cl21.48to53.42, P<0.00001), but no benefit on reducing triglyceride (MD=0.78,95%Cl0.13to1.43, P=0.02) and low density lipoprotein(MD=2.18,95%Cl1.63to2.74, P=0.27).A single study repored Salvia Miltiorrhiza Powder Injection had a positive effect on plasma albumin (MD=5.12,95%Cl3.94to6.30). No study reported adverse events and economic index (eg.cost)ConelusionDanshen preparations may have some positive effects in treating NS by increasing plasma albumin, reducing total urinary protein quantitation., blood cholesterol and serum creatinine。However, limited by the lack of high quality clinical studies and quality evidence (low or very low quality evidence assessed by GRADEpro), we are unable to recommend Danshen preparations for NS. Large, properly randomised, placebo-controlled, double-blind studies are required.