Abstracts of the 2025 Annual Meeting of the ALEH
More infoSevere alcohol-associated hepatitis (SAAH) is characterized by antioxidant deficiencies and heightened inflammation. Omega-5 fatty acid (nano=Granagard®) has been shown antioxidant and anti-inflammatory properties.
To evaluate the efficacy of Omega-5 fatty acid (nano) as an adjuvant to prednisone in modulating oxidative and proinflammatory parameters in SAAH.
Patients / Materials and MethodsRandomized, double-blind, placebo-controlled clinical trial (NCT 03732586) was conducted at a single center in Mexico. Patients with confirmed SAAH (MDF ≥32) were randomly assigned to Group P (prednisone 40 mg/day + placebo) or Group T (prednisone 40 mg/day + Omega-5 (nano) at 1.28 g/day), administered for 28 days. Biochemical markers of liver function, nutritional evaluation, malondialdehyde (MDA), protein carbonyls (PC), reduced glutathione (GSH), oxidized glutathione (GSSG), and the GSH/GSSG ratio in blood were assessed. Additionally, cytokines, chemokines MCP-1, CXCL-8 and 10) and growth factors (IGFBP-1 to 7), were measured at baseline (day 0) and on days 7, 14, and 28.
ResultsBoth groups exhibited similar steroid responses with Lille scores (p> 0.05). Liver function tests revealed improved in Group T at day 28 (p<0.05). Analysis for lipid peroxidation (MDA) was improved (p=0.001) at 28 days in group T vs group P. The GSH/GSSG ratio also showed differences with the use of Omega-5. IL-10 levels (pg/mL) significantly increased in Group T, while MCP-1, CXCL-8 and CXCL10 levels (pg/mL) showed marked reduction by day 28 vs day 0. Additionally, IGFBP 1, 2,3 and 7 levels (ng/mL) in Group T were significantly reduced.
ConclusionsAddition to Omega-5 fatty acid (nano) to prednisone strongly showed a beneficial effect in SAAH, promoting the reduction of oxidative stress, modulating cytokines and IGFBP levels. A phase 3 clinical trial is performed to further elucidate molecular mechanisms and explore the correct dosing regimens.
Conflict of interest: None
