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

Abstract

AIMTo evaluate the efficacy and safety of HL tablet extracted from magnolia officinalis for treating patients with nonalcoholic fatty liver disease (NAFLD).METHODSSeventy-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).RESULTSThe 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.CONCLUSIONHL tablet is effective in reducing HFC without any negative lipid profiles, BMI changes and adverse effects.

Efficacy and safety of traditional Chinese medicines for non-alcoholic fatty liver disease: a systematic literature review of randomized controlled trials

“… IM T: 1–12 years C: 1–13 year 140 (70, 70) 83, 57 T: 42.9 ± 5.3 C: 43.2 ± 5.7 8 Jiang et al, 2017 [ 41 ] Dahuang Lidan capsule Rhei Radix Et Rhizoma, Phyllanthi Fructus and Radix Gymnadeniae IM N/A 144 (72, 72) 104, 40 T: 43.0 ± 0.03 C: 43.4 ± 7.60 9 Yang et al, 2017 [ 53 ] Cigu Xiaozhi capsule Cremastrae Pseudobulbus, Alismatis Rhizoma, Crataegi Fructus, Salviae Miltiorrhizae Radix Et Rhizoma, Radix Bupleuri, Pinelliae Rhizoma Praeparatum, Cassiae Semen, etc. WM N/A 87 (43, 44) 50, 37 T: 49.02 ± 11.19 C: 50.63 ± 10.97 10 Jeong et al, 2017 [ 28 ] HL tablet Extract of Magnolia officinalis WM N/A 72 (22, 23, 23)* 54, 18 H: 39.1 ± 9.5 L: 45.5 ± 11.5 C: 42.7 ± 11.2 11 Sun et al, 2017 [ 68 ] Jianpi Qushi prescription Codonopsis Radix, Poria, Microctis Folium, Microctis Folium, Crataegi Fructus, Cassiae Semen, Pogostemonis Herba, etc. IM T: 3.41 ± 2.56 years C: 4.02 ± 2.73 years 120 (60, 60) 67, 53 T: 34.61 ± 12.47 C: 36.37 ± 10.25 12 Niu, 2016 [ 48 ] Shugan Jianpi Huatan decoction Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria, Alismatis Rhizoma, Coicis Semen, Artemisia Scopariae Herba, Radix Bupl...…”

“… Liver function Out of the 47 trials which tested the related biochemical response measures of liver function, 19 trials reported the changes in AST, ALT, GGT, 17 trials reported ALT and AST change, 4 trials reported ALT, AST, ALP and GGT change, and 4 trials also reported TB. One trial also reported the MRS and free fatty acid to assess of hepatic fat content [ 28 ]. Blood sugar Out of the 12 trials that reported the results of the related biochemical response measures of blood sugar, 7 trials reported FBG, FNIs, HOMA-IR results, and 1 trial [ 42 ] reported the Hb1A results.…”

“…Liver function Out of the 47 trials which tested the related biochemical response measures of liver function, 19 trials reported the changes in AST, ALT, GGT, 17 trials reported ALT and AST change, 4 trials reported ALT, AST, ALP and GGT change, and 4 trials also reported TB. One trial also reported the MRS and free fatty acid to assess of hepatic fat content [ 28 ]. …”

“… Allocation (sequence generation and allocation concealment) Two trials reported detailed information on allocation concealment methods and were regarded as adequate [ 26 , 27 ], and 51 trials were assessed at unclear risk of bias due to not providing the specific methods of allocation concealment. Blinding Two trials claimed that they respectively used single-blinding or double-blinding but they did not report who was blinded [ 28 , 58 ]. Two trial reported that it used blindness-method evaluation [ 51 , 52 ].…”

“…One trial gave unclear information on withdrawals and loss to follow-up [ 58 ]. 18 trials reported participants lost to follow-up without providing the reasons for the loss and were assessed as trials with unclear risk of bias [ 28 , 30 – 32 , 43 – 45 , 50 , 55 , 62 – 70 ]. The remaining trials reported that no participants were lost to follow-up during the trial.…”