Immunomodulatory and Anti-Inflammatory Effects of Ketotifen Versus Vitamin E in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Pilot Study
Abstract
Background: Non-alcoholic fatty liver disease (NAFLD) represents a prevalent, long-standing hepatic condition marked by the accumulation of fat in the liver and varying degrees of fibrotic changes. Ketotifen, a mast cell stabilizer, has been proposed to modulate inflammation and fibrogenesis, but clinical evidence is limited.
Objective: To assess the effectiveness and safety of ketotifen vs vitamin E in individuals with NAFLD. The primary outcome was the change in hepatic steatosis, while the secondary outcomes included modifications in fibrosis-related indices and inflammatory biomarkers. In addition to other biochemical, anthropometric, and metabolic parameters.
Methods: In this randomized study, 60 individuals with NAFLD were allocated in a 1:1 ratio into two groups. The vitamin E group was treated with vitamin E, and the ketotifen group received ketotifen for six months. Anthropometric parameters, liver steatosis and fibrosis, lipid profile, glycemic markers, liver enzymes, matrix metalloproteinase (MMP)-9, and tumor necrosis factor (TNF)-α were measured before and after 6 months.
Results: Ketotifen treatment resulted in significant improvements in hepatic steatosis and disease activity compared with vitamin E, including lower steatosis and FibroScan-AST (FAST) score. Fibrosis severity was also reduced, with significant decreases in fibrosis score and fibrosis index (FIB-4) index, whereas Metabolic-Associated Steatosis Combined with Keratin-18 (MACK-3) score showed no…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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