Syndrome Drift And It’s Significance In Syndrome Of Liver Depression And Spleen Deficiency In Non-alcoholic Fatty Liver Disease

Background:Syndrome drift, guided by the basic theory of Tradition Chinese Medcine (TCM), based on the result of previous research and "genetic drift", is defined as that the emergence of new syndrome(s) neither change the original syndrome pattern, nor form any other syndrome pattern.Objective:To recognize syndrome drift in syndrome of liver depression and spleen deficiency in non-alcoholic fatty liver disease (NAFLD), and to explore the influence and significance of syndrome drift on the outcome of syndrome efficacy evaluation.Methods:In this study, a total of161NAFLD patients with syndrome of liver depression and spleen deficiency were enrolled In accordance with their condition and willingness,71cases (control group) received basic therapy for3months, while another90received treatment of XiaoYao San (differential group) in combination with basic therapy for3months. All patients followed up weekly, the current Nimodipine method and the modified Nimodipine method which integral of new syndrome(s) occurs during treatment were involved in,were used to evaluate syndrome efficacy separately. All data used SPSS17statistical software package for statistical analysis,95%confidence interval (95%CI) for a rate computing by PASS software (Version11.0). Kaplan-Meier test for testing cumulative incidence of the syndrome drift, Log-Rank test for testing cumulative incidence difference of syndromes drift, Marginal Homogeneity test for testing the significance between syndrome efficacies and McNemar test to test the significance between overall rates of syndrome efficacy, resulted from the current Nimodipine method and the modified Nimodipine method respectively.Results: Syndrome drift was observed in8(11.3%,95%CI:3.9%,18.7%) of71patients in control group, and in26(28.9%,95%CI:19.5%,38.3%) of90patients in differential treatment group (χ2=7.398,p=0.007). Both syndrome efficacy (Std. MH Statistic=-3.646,p<0.001) and overall rate of syndrome efficacy (80.0%versus66.7%,p<0.001), of the current Nimodipine method was significantly overvalued.Conclusion: Syndrome drift is common in syndrome of liver depression and spleen deficiency in NAFLD and induces a biased estimate (overvalue) at the evaluation of syndrome efficacy.