Efficacy of a Chinese herbal formula on hepatitis B e antigen-positive chronic hepatitis B patients.

BACKGROUND: No guideline recommends antiviral therapy for hepatitis B e antigen (HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus (HBV) DNA viral load. AIM: To evaluate the feasibility and safety of a Chinese herbal formula as a therapeutic option for chronic HBV infection. METHODS: In total, 395 patients (30-65 years old) with confirmed HBeAg-positive chronic hepatitis B infection and persistently normal alanine aminotransferase were randomized to receive either Chinese herbal formula or placebo for 96 wk. Endpoints to evaluate therapeutic efficacy included: (1) HBV DNA levels decreased to less than 4 log10 IU/mL at weeks 48 and 96; and (2) HBeAg clearance and seroconversion rates at weeks 48 and 96. RESULTS: HBV DNA levels ≤ 4 log10 IU/mL were 10.05% at week 48 and 18.59% at week 96 in the treatment group. The HBeAg clearance and conversion rates were 8.54% and 8.04% at week 48 and 16.08% and 14.57% at week 96, respectively. However, HBV DNA levels ≤ 4 log10 IU/mL were 2.55% and 2.55% at weeks 48 and 96, respectively, and the HBeAg clearance rates were 3.06% and 5.61% at weeks 48 and 96, respectively, in the control group. The quantitative hepatitis B surface antigen and HBeAg levels at baseline and changes during the treatment period as well as the alanine aminotransferase elevation at weeks 12 and 24 were strong predictors of HBeAg clearance. CONCLUSION: High rates of HBV DNA reduction, HBeAg clearance and seroconversion could be achieved with Chinese herbal formula treatments, and the treatments were relatively safe for HBeAg-positive chronic hepatitis B-infected patients with persistently normal alanine aminotransferase. The ability of the compound to modulate host immune function probably contributed to this effect.

Metabolomics profiling in a mouse model reveals protective effect of Sancao granule on Con A-Induced liver injury.

ETHNOPHARMACOLOGICAL RELEVANCE: Sancao granule (SCG) is a traditional Chinese herb formula, which has been used for autoimmune liver disease for decades. Previous study demonstrated that there was an exactly therapeutic effect of SCG on autoimmune hepatitis (AIH) by improving liver function and alleviating the clinical symptoms. However, studies of the mechanism by which SCG alleviates Con A-induced liver injury (CILI) should be complemented. MATERIALS AND METHODS: An ultraperformance liquid chromatography with quadrupole time-of-flight mass spectrometry (UHPLC-QTOF/MS)-based metabolomics approach combined with principle component analysis (PCA) and orthogonal projection to latent structures discriminate analysis (OPLS-DA) were integrated applied to obtain metabolites for clarifying mechanisms of disease. RESULTS: In accordance with previously study, the present study demonstrated that SCG could obviously improve the liver injury in mouse induced by Con A via downregulating serum biochemical indexes, alleviating the histological damage and inhibiting the neutrophil infiltration in liver tissues. Different expression of 9 metabolites related to 8 pathways, including fatty acid biosynthesis, arachidonic acid metabolisms, linoleic acid metabolisms, sphingolipid metabolisms, fatty acid elongation in mitochondria, glycerophospholipid metabolism, fatty acid metabolism, pyrimidine metabolism were demonstrated responsible for the efficacy of SCG in treating CILI. CONCLUSION: In sum up, SCG has been indicated favorable therapeutic effect on Con A induced liver injury. And metabolomics could be a promising approach, which provide insights into mechanisms of SCG in treating CILI.

Short-term efficacy of treating hepatitis B virus-related acute-on-chronic liver failure based on cold pattern differentiation with hot herbs: A randomized controlled trial.

OBJECTIVE: To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction (, YCZFD) in the treatment of acute-on-chronic liver failure caused by hepatitis B virus (HBV-ACLF) with cold pattern in Chinese medicine (CM). METHODS: This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine (WM) for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM (integrative treatment) or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease (MELD) score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. RESULTS: The mortality was decreased 14.28% in the integrative treatment group compared with WM group (χ(2) =6.156, P=0.013). The integrative treatment was found to signifificantly improve the MELD score (t=2.353, P=0.020). There were statistically signifificant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups (P<0.05 or P<0.01). The complications of ascites (χ(2)=9.033, P=0.003) and spontaneous bacteria peritonitis (χ(2)=4.194, P=0.041) were improved signifificantly in the integrative treatment group. No serious adverse event was reported. CONCLUSIONS: The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle "treating cold pattern with hot herbs" remains valuable to the clinical therapy. (Trial registration No. ChiCTR-TRC-10000766).

Syndrome classification based on manifold ranking for viral hepatitis.

Treatment determination based on syndrome differentiation is the key of Chinese medicine. A feasible way of improving the clinical therapy effectiveness is needed to correctly differentiate the syndrome classifications based on the clinical manifestations. In this paper, a novel data mining method based on manifold ranking (MR) is proposed to explore the relation between syndromes and symptoms for viral hepatitis. Since MR could take the symptom data with expert differentiation and the symptom data without expert differentiation into the task of syndrome classification, the clinical information used for modeling the syndrome features is greatly enlarged so as to improve the precise of syndrome classification. In addition, the proposed method of syndrome classification could also avoid two disadvantages in previous methods: linear relation of the clinical data and mutually exclusive symptoms among different syndromes. And it could help exploit the latent relation between syndromes and symptoms more effectively. Better performance of syndrome classification is able to be achieved according to the experimental results and the clinical experts.