Clinical study on treatment of chronic viral cholestatic hepatitis with chishaodanpi decoction

To observe the therapeutic effect of Chishaodanpi decoction (CSDPD) on chronic viral cholestatic hepatitis.

A total of 107 subjects with chronic viral cholestatic hepatitis were enrolled in our hospital from March 2007 to November 2012. Patients were randomly divided into treatment (54 cases) and control groups (53 cases). The control group was treated with potassium magnesium aspartate, diammonium glycyrrhizinate, glucurolactone, vitamin C, and lamivudine, once a day. The treatment group was treated with modified CSDPD, 100 mL a time, twice a day, in addition to the treatment given to the control group. The patients in both groups were treated for 8 weeks. The main symptoms and signs were recorded every day throughout the clinical trial. Before and after the trial, changes in liver function including total bilirubin (TBil), direct bilirubin (DBil), total bile acid (TBA), and the activities of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ-glutamyl transferase (γ-GT), were all detected. Adverse reactions were also recorded.

There were no differences in gender, age, disease duration, symptoms, signs, or laboratory findings between the two groups (P > 0.05). After an 8-week treatment, improvements in jaundice, weakness, poor appetite, abdominal distention, and skin itching were significantly better in the treatment group than in the control group (P < 0.05). In the treatment group, 43 patients had a significant response to the treatment, seven patients had a response, and four patients had no response, with 21, 12, and 20 patients in the control group, respectively. The total effective rate was 92.6% in the treatment group and 62.3% in the control group, which was a significant difference (P < 0.05). The levels of TBil, DBil, TBA, ALP, ALT, AST, and γ-GT in both groups were significantly lower after treatment, and were significantly different between the two groups (P < 0.05). A few patients in the treatment group had mild adverse effects such as increased bowel movement frequency and mild stomach-ache. No other adverse reactions were observed in either group.