| Objectives Using the theory and method of Evidence-Based Medicine, evaluated the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for liver disease.Method Randomized controlled trials comparing PPC versus placebo/no treatment for liver disease were identified by electronic and manual searches. No blinding, language and publishing were applied. The methodological quality of trials was assessed in four aspect: generation of the allocation sequence, allocation concealment, blinding and follow-up. Two reviewers independently assessed the methodological quality and extracted data on patients, methods, interventions and outcomes.All the data was processed by qualitative analysis or Meta-analysis. Sub-group analysis and sensitivity analysis will made. Sensitivity analysis will be made in the following way. The Meta-analysis only included the large sample size RCT, long-term treat RCT or high methodological quality RCT. We analyzed the data of viral hepatitis sub-group, fatty liver sub-group and chronic hepatitis sub-group.All the data were analyzed by the software of RevMan4.2 supplied by the Cochrane Collaboration.Result Twenty trials involving 1785 patients were included. The methodological quality was high in fifteen randomized controlled trials andthe rest was low. Five articles reported the early mortality of PPC for liver disease. Thirteen articles reported the efficacy of PPC. Six studies concerned for the histology. Six studies concerned for liver biochemistry. No serious adverse events were reported.Five studies involving 266 patients concerned for mortality. Meta-analysis indicated that PPC can reduce the early mortality (19.5%v 43%, relative risk 0.65, 95%CI0.48~0.89, P=0.007). Sub-group analysis (liver failure group ) supported the result. Funnel plot indicate that there is a report bias. Methodological quality of included studies was low. These may influence the conclusion.Thirteen studies involving 999 patients concerned for efficacy of PPC for liver disease. The combined results showed that PPC had positive effect on liver diseases. (63.8%vs42.8%;RR1.52; 95%CI: 1.20-1.81, PO.00001). Funnel plot showed little report bias. Sub-group analysis (viral hepatitis group ^ alcoholic fatty liver group and chronic liver disease group) consolidated the conclusion, sensitivity analysis(large sample size RCT , long-term treat RCT and high methodological quality RCT) supported the result.Five articles include 226 patients reported the biopsy improving by PPC. The combined results showed that the drug had positive effect for liver disease. (36.1%vsl3.0%; OR7.64; 95%CI 3.14-10.61; P (0.001;) Butthe result may be changed by a multi-center randomized placebo controlled study .In this study ,the rate of lost follow-up beyond 20% 0 The study was excluded from the meta-analysis. The sample size of RCTs may influence the result too.Six studies which included 446 patients reports the liver biochemistry. Because the defect of the statistic analysis (the study just supplied means and standard deviation of the beginning and the final of the two compared group.Absence the variety of means and standard deviation )<, We can not make ameta-analysis. But, these articles indicated that PPC had positive effect onliver biochemistry for liver disease.Conclusion Based on the review, PPC can improve the efficacy of liverdisease and relieve the clinic symptoms and signs. It had the same conclusionfor viral hepatitis > fatty liver and chronic liver disease.PPC had positive effect on histology ^ liver biochemistry and earlymortality for liver disease. But, the conclusion should be proved by thefollowing clinical trials.
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