Copyright
©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
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
Jae Yoon Jeong, Joo Hyun Sohn, Yang Hyun Baek, Yong Kyun Cho, Yongsoo Kim, Hyeonjin Kim
Jae Yoon Jeong, Joo Hyun Sohn, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea
Yang Hyun Baek, Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan 49201, South Korea
Yong Kyun Cho, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, South Korea
Yongsoo Kim, Department of Radiology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea
Hyeonjin Kim, Department of Radiology, Seoul National University Hospital, Seoul 03080, South Korea
Author contributions: All authors participated in the interpretation of study results, and in the drafting, critical revision, and approval of the final version of the manuscript; Sohn JH, Baek YH and Cho YK performed the research; Jeong JY, Sohn JH and Kim H collected and analysed the data; Sohn JH designed the research study; Jeong JY and Kim H wrote the paper; Kim Y contributed to the design of the study; all authors have approved the final version of the article, including the authorship list.
Institutional review board statement: The study was reviewed and approved by the Medical Ethics Committee of Hanyang University Guri Hospital, Dong-A University Hospital and Kangbuk Samsung Hospital.
Informed consent statement: All study participants, or their legal guardian provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors have no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Joo Hyun Sohn, MD, PhD, Professor of Medicine, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, 153 Gyeongchun-ro, Guri 11923, South Korea.
sonjh@hanyang.ac.kr
Telephone: +82-31-5602225 Fax: +82-31-5552998
Received: February 2, 2017
Peer-review started: February 9, 2017
First decision: April 21, 2017
Revised: May 12, 2017
Accepted: July 12, 2017
Article in press: July 12, 2017
Published online: August 28, 2017
Processing time: 206 Days and 11.4 Hours
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.
Core tip: The prevalence of nonalcoholic fatty liver disease (NAFLD) is growing gradually with the increase in population age and obesity, while effective and safe drugs for NAFLD are not yet available. HL tablet, a new botanic drug extracted from Magnolia officinalis, is effective in reducing hepatic fat content without any negative lipid profiles, body mass index changes and adverse effects.
