Abstract
Aim. To evaluate and predict the therapeutic efficacy of Fuzheng-Huayu tablet (FZHY) based traditional Chinese Medicine (TCM) syndrome differentiation or TCM symptoms on chronic hepatitis B caused cirrhosis (HBC). Methods. The trial was designed according to CONSORT statement. It was a multi-center, double-blind, randomized, placebo-controlled trail. Several clinical parameters, Child-Pugh classification and TCM symptoms were detected and evaluated. The FZHY efficacy was predicted by an established Bayes forecasting method following the Bayes classification model. Results. The levels of HA and TCM syndrome score in FZHY group were significantly decreased (P < 0.05) compared to placebo group, respectively. The efficacy of FZHY on TCM syndrome score in HBC patients with some TCM syndromes was better. In TCM syndrome score evaluation, there were 53 effective and 22 invalid in FZHY group. TCM symptoms predicted FZHY efficacy on HBC were close to Child-Pugh score prediction. Conclusion. FZHY decreases the levels of HA and TCM syndrome scores, improves the life quality of HBC patients. Moreover, there were different therapeutic efficacies among different TCM syndromes, indicating that accurate TCM syndrome differentiation might guide the better TCM treatment. Furthermore, the FZHY efficacy was able to predict by Bayes forecasting method through the alteration of TCM symptoms.
Highlights
Hepatitis B virus (HBV) infection is a major health problem in China
In the clinical practices of traditional Chinese medicine (TCM), the efficacy of Fuzheng-Huayu tablet (FZHY) is based on TCM syndrome, which is the characteristic in body tired and weak, no appetite, face pale white or dark sluggish, tongue dark, or bruises in hepatitis-B-caused cirrhosis (HBC) patients
The 180 patients included were randomly allocated with the ratio of 1 : 1. In the process of followup, 15 patients in FZHY group and 18 patients in placebo group were lost; data from the other 75 patients in FZHY group and 72 patients in placebo group were available for further analysis
Summary
Hepatitis B virus (HBV) infection is a major health problem in China It is one of the important reasons for virusrelated liver diseases, such as chronic hepatitis B (CHB), liver cirrhosis (LC), and hepatocellular carcinoma (HCC) [1]. In the clinical practices of traditional Chinese medicine (TCM), the efficacy of FZHY is based on TCM syndrome, which is the characteristic in body tired and weak, no appetite, face pale white or dark sluggish, tongue dark, or bruises in HBC patients. Evidence-Based Complementary and Alternative Medicine inhibiting the activation of hepatic satellite cells in animal model [8]. It has less clinical efficacy evaluation on HBC. The aim was to evaluate and predict FZHY efficacy on HBC with or without TCM syndrome differentiation through the outcome assessment of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), hyaluronic acid (HA), Child-Pugh score and TCM syndrome score, and the prediction of FZHY efficacy using Bayes forecasting method
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