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

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221 patients were analyzed in the full analysis set (FAS), 205 in the per protocol set (PPS), and 3 patients were withdrawn prematurely.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.