The Efficacy and Safety of Traditional Chinese Medicine (Jiang Zhi Granule) for Nonalcoholic Fatty Liver: A Multicenter, Randomized, Placebo-Controlled Study

摘要

Objective. To evaluate the efficacy and safety of Jiang Zhi Granule (JZG), a Chinese herbal formula, in patients with nonalcoholic fatty liver (NAFL).Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel clinical trial was conducted for 24 weeks in 224 patients with NAFL at 6 university-affiliated hospitals. Patients were randomized 1 : 1 to receive JZG and placebo, respectively. Primary outcome was the change of liver to spleen ratio (L/S ratio) over computed tomography (CT). Secondary outcomes included body mass index (BMI), serum triglyceride (TG), and total cholesterol (TC) levels.Results. Of all the 224 eligible patients, 221 patients were analyzed in the full analysis set (FAS), 205 in the per protocol set (PPS), and 3 patients were withdrawn prematurely. For FAS, JZG significantly increased L/S ratio from 0.74 ± 0.21 to 0.99 ± 0.24 compared to that from 0.79 ± 0.18 to 0.85 ± 0.27 in placebo group (P=0.0011). For PPS, it showed an increase of 0.26 ± 0.23 of L/S ratio in the patients on JZG versus 0.07 ± 0.22 in those on placebo (P=0.0003). Superiority of JZG over placebo was also observed with greater reduction in BMI (P<0.05) in both FAS and PPS. No observable difference in decrease of serum TC and TG was recorded (P>0.05). There were no serious adverse events (AEs) in the study process and safety indices were normal in both groups.Conclusions. The Chinese herbal formula JZG was found to be superior to placebo in increasing L/S ratio and reducing BMI in NAFL patients. It was also well tolerated in patients and might be a safe and effective medicine for NAFL.