BACKGROUND: Currently, the managment of non-alco-holic fatty liver disease (NAFLD) is less than certain. Somecholeretic might be of potential benefit and deserve furtherevaluation. This multicenter clinical trial was designed toevaluate the efficacy and safety of Chinese herbal medicineDanning Pian ( composed of rhubarb, grant knotweed,dried green orange peel and dried old orange peel) in theshort-term treatment of patients with NAFLD.METHODS: The efficacy and safety of Danning Pian in theshort-term treatment of NAFLD were investigated in 232patients by a multicenter clinical trial during the period ofJuly 1999 to February 2000. The patients consisting of 189males and 43 females with an average age of 46.1 ±8.7 yearswere given 3-5 tablets of Danning Pian orally thrice dailyfor 3 months in addition to the other comprehensive thera-py. The effects of Danning Pian on NAFLD were evaluatedby the improvement of clinical symptoms, blood lipids,hepatic enzymes and liver ultrasonographic features. Thedrug safety was monitored by physical examinations, vitalsigns, and laboratory tests in addition to the assessment ofthe adverse events.RESULTS: All the enrolled patients completed the study ex-cept one whose serum ALT level was moderately increasedduring the therapy with Danning Pian. The effective rate ofDanning 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 for3 months. However, the reduction of excessive bodyweight and waistline did not reach the significant level onthe whole after the therapy. The general mild adverseevents included diarrhea, skin rash and mild to moderateelevation of serum ALT level. The incidence of adverse re-action was 15.1%.CONCLUSION: The data of this trial indicate that DanningPian is effective and safe, generally well-tolerated withoutsevere adverse events, in the treatment of patients withNAFLD over a 3-month period. BACKGROUND: Currently, the managment of non-alco-holic fatty liver disease (NAFLD) is less than certain. Somecholeretic might be of potential benefit and deserve furtherevaluation. 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. METHHODS: 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 June 1999 to February 2000. The patient consisting of 189 males and 43 females with an average age of 46.1 ± 8.7 yearswere given 3-5 tablets of Danning Pian orally thrice daily for 3 months in addition to the other comprehensive thera-py The effects of Danning Pian on NAFLD were evaluated by the improvement of clinical symptoms, blood lipids, hepatic enzymes and liver ultrasonographic featu res. Thedrug safety was monitored by physical examinations, vitalsigns, and laboratory tests in addition to the assessment of the adverse events .RESULTS: All the enrolled patients completed the study ex-cept one whose serum ALT level was moderately increased dormant the therapy with Danning Pian. The effective rate of Daning 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 bodyweight and waistline did not reach the significant level on the whole after the therapy. The general mild adverseevents included diarrhea, skin rash and mild to moderate elevation of serum ALT level. The incidence of adverse re-action was 15.1% .CONCLUSION: The data of this trial indicate that DanningPian is effective and safe, generally well-tolerated without serious adverse events, in the treatment of patients with NAFLD over a 3-month period.