Jeong JY, et al. – The efficacy and safety of HL tablet extracted from magnolia officinalis for treating patients with nonalcoholic fatty liver disease (NAFLD) were assessed in this placebo–controlled, randomized, phase II study. In reducing hepatic fat content (HFC), HL tablet was effective without any negative lipid profiles, body mass index (BMI) changes, and adverse effects.

• The clinicians randomly assigned 74 patients with NAFLD diagnosed by ultrasonography to 3 groups given high dose (400 mg) HL tablet, low dose (133.4 mg) HL tablet and placebo, respectively, daily for 12 wk.
• Post-treatment change in hepatic fat content (HFC) measured by magnetic resonance spectroscopy was the primary endpoint.
• Changes of serum aspartate aminotransferase, alanine aminotransferase (ALT), cholesterol, triglyceride, free fatty acid, homeostasis model assessment-estimated insulin resistance, and body mass index (BMI) were included as secondary endpoints.

• After 12 wk of treatment, the mean HFC of the high dose HL group declined significantly (high dose vs placebo, P = 0.033; low dose vs placebo, P = 0.386), but not of the low dose group.
• In the high dose group (P = 0.018), the mean changes of HFC from baseline at week 12 were -1.7% ± 3.1% , -1.21% ± 4.97% in the low dose group (P = 0.254) and 0.61% ± 3.87% in the placebo group (relative changes compared to baseline, high dose were: -12.1% ± 23.5%, low dose: -3.2% ± 32.0%, and placebo: 7.6% ± 44.0%).
• Also, serum ALT levels tended to decrease in the groups receiving HL tablet while other factors were unaffected.
• During the study, the clinicians found no moderate or severe treatment-related safety issues.