Open AccessAn Open-Label Exploratory Clinical Trial Evaluating the Effects of GLS (Coptidis Rhizoma-Evodiae Fructus 2 : 1) on Fibroblast Growth Factor 21 in Patients with Nonalcoholic Fatty Liver Disease
Author(s) -
Yang Zhang,
Jiaoyang Luo,
Yan-Ge Li,
Hongfang Fu,
Yang Fang,
Xiao-Yu Hu
Publication year - 2022
Publication title -
evidence-based complementary and alternative medicine
Language(s) - English
Resource type - Journals
eISSN - 1741-4288
pISSN - 1741-427X
DOI - 10.1155/2022/4583645
Subject(s) - nonalcoholic fatty liver disease , medicine , aspartate transaminase , waist , triglyceride , alanine transaminase , endocrinology , transaminase , body mass index , fatty liver , gastroenterology , cholesterol , alkaline phosphatase , biochemistry , chemistry , disease , enzyme
Background and Aim. Coptidis Rhizoma and Evodiae Fructus share the potential to treat nonalcoholic fatty liver disease (NAFLD). Increased fibroblast growth factor (FGF) 21 secreted by hepatocytes is an important self-help behavior in NAFLD. We investigated the effects of GLS (Coptidis Rhizoma-Evodiae Fructus 2 : 1) for both their clinical effect and their serum FGF-21 levels in NAFLD patients. Methods. In a 12-week, open-label, exploratory clinical trial, 126 NAFLD patients were randomly divided into the GLS group (lifestyle intervention plus GLS) or the polyene phosphatidylcholine (PPC) group (lifestyle intervention plus PPC). Random numbers generated by DPS software were used in combination with opaque, sealed envelopes for allocation concealment. At baseline as well as at the end of the study, anthropometric parameters, glucose, lipids, hepatic enzymes, and FGF 21 were measured, with hepatic fat accumulation assessed by ultrasound (US) and US-based controlled attenuation parameter (CAP). Results. 119 patients completed the study. Baseline parameters did not significantly differ between the two groups ( P > 0.05 ). Compared with PPC, GLS decreased more significantly in hepatic fat accumulation, body weight index, waist circumference, waist-to-hip ratio, serum glucose, total cholesterol, triglyceride, low-density lipoprotein cholesterol, alanine transaminase, aspartate transaminase, gamma-glutamyl transferase, and FGF 21 ( P < 0.05 ). The effects of GLS on waist circumference, waist-to-hip ratio, CAP, and gamma-glutamyl transferase (GGT) were positively correlated with serum FGF 21 (r = 0.343, 0.342, 0.315, and 0.374, respectively, P < 0.05 ). The GGT and FGF-21 changes were also confirmed by multiple linear regression analysis (B, 0.777; 95% CI: 0.307–1.247, P < 0.05 ). Conclusion. GLS has a significant hepatoprotective effect on NAFLD patients, causing a decrease in FGF-21 secretion in response to the damage itself.