Gandouling improves Wilson’s disease liver fibrosis by modulating intestinal flora: a randomized, double-blind, placebo-controlled trial

Abstract

Based on liver FibroTouch technology combined with 16S rRNA gene sequencing technology, this study aimed to explore the changes of liver fibrosis indexes and intestinal flora in Wilson's disease (WD) improved by Gandouling (GDL). Ninety patients with WD hepatic fibrosis at the Brain Disease Center of the Anhui Provincial Hospital of Traditional Chinese Medicine were included and randomly divided into an observation group and a control group for a 48-day randomized, double-blind, placebo-controlled trial. Patients in both groups were treated with conventional sodium dimercaptopropanesulfonate, to which GDL was added in the observation group, while the control group was given the corresponding placebo treatment. Before and after treatment, liver stiffness was assessed, blood samples were collected for laboratory tests, and stool samples were collected for 16S rRNA sequencing. Supplementation with GDL significantly improved liver stiffness and non-invasive liver fibrosis modeling indicators, while alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, bile acid, platelets, hyaluronic acid and laminin levels were also significantly improved (p<0.05). Other parameters showed no significant changes. The results of intestinal microbial testing showed that the microbial diversity and composition of the patients in the observation group underwent significant optimization, in which the number of probiotics rose but the number of pathogenic and opportunistic pathogens declined and even basically returned to the normal range. GDL combined with conventional liver-protecting and copper-removing treatments can effectively improve patients’ liver fibrosis-related indexes. Furthermore, GDL has the ability to regulate the composition and diversity of the intestinal flora and promote reconstruction of the intestinal microbial community, which in turn may reverse the state of hepatic fibrosis.