Evaluating the efficacy and safety of Danning Pian in the short-term treatment of patients with non-alcoholic fatty liver disease: a multicenter clinical trial.

BACKGROUND

Currently, the management of non-alcoholic fatty liver disease (NAFLD) is less than certain. Some choleretic might be of potential benefit and deserve further evaluation. This multicenter clinical trial was designed to evaluate the efficacy and safety of Chinese herbal medicine Danning Pian (composed of rhubarb, grant knotweed, dried green orange peel and dried old orange peel) in the short-term treatment of patients with NAFLD.

METHODS

The efficacy and safety of Danning Pian in the short-term treatment of NAFLD were investigated in 232 patients by a multicenter clinical trial during the period of July 1999 to February 2000. The patients consisting of 189 males and 43 females with an average age of 46.1+/-8.7 years were given 3-5 tablets of Danning Pian orally thrice daily for 3 months in addition to the other comprehensive therapy. The effects of Danning Pian on NAFLD were evaluated by the improvement of clinical symptoms, blood lipids, hepatic enzymes and liver ultrasonographic features. The drug safety was monitored by physical examinations, vital signs, and laboratory tests in addition to the assessment of the adverse events.

RESULTS

All the enrolled patients completed the study except one whose serum ALT level was moderately increased during the therapy with Danning Pian. The effective rate of Danning Pian for the improvement of clinical symptoms, serum ALT levels, blood lipid and fatty liver was 85.8%, 78.2%, 39.6% and 34.0% respectively after the therapy for 3 months. However, the reduction of excessive body weight and waistline did not reach the significant level on the whole after the therapy. The general mild adverse events included diarrhea, skin rash and mild to moderate elevation of serum ALT level. The incidence of adverse reaction was 15.1%.

CONCLUSION

The data of this trial indicate that Danning Pian is effective and safe, generally well-tolerated without severe adverse events, in the treatment of patients with NAFLD over a 3-month period.