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World J Gastroenterol. 2017 Aug 28;23(32):5977-5985. doi: 10.3748/wjg.v23.i32.5977.

New botanical drug, HL tablet, reduces hepatic fat as measured by magnetic resonance spectroscopy in patients with nonalcoholic fatty liver disease: A placebo-controlled, randomized, phase II trial.

Author information

1
Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea.
2
Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea. sonjh@hanyang.ac.kr.
3
Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan 49201, South Korea.
4
Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, South Korea.
5
Department of Radiology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea.
6
Department of Radiology, Seoul National University Hospital, Seoul 03080, South Korea.

Abstract

AIM:

To evaluate the efficacy and safety of HL tablet extracted from magnolia officinalis for treating patients with nonalcoholic fatty liver disease (NAFLD).

METHODS:

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

RESULTS:

The mean HFC of the high dose HL group, but not of the low dose group, declined significantly after 12 wk of treatment (high dose vs placebo, P = 0.033; low dose vs placebo, P = 0.386). The mean changes of HFC from baseline at week 12 were -1.7% ± 3.1% in the high dose group (P = 0.018), -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%). Serum ALT levels also tended to decrease in the groups receiving HL tablet while other factors were unaffected. There were no moderate or severe treatment-related safety issues during the study.

CONCLUSION:

HL tablet is effective in reducing HFC without any negative lipid profiles, BMI changes and adverse effects.

KEYWORDS:

Botanical drug; Magnetic resonance spectroscopy; Magnolia officinali; Nonalcoholic fatty liver disease; Randomized controlled trial

PMID:
28932090
PMCID:
PMC5583583
DOI:
10.3748/wjg.v23.i32.5977
[Indexed for MEDLINE]
Free PMC Article

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