Did you know that nearly 30% of the global population is affected by Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)? This silent epidemic is increasing the burden of liver-related complications, including cirrhosis and liver cancer. MASH, the progressive form of MASLD, is characterized by hepatocellular damage and inflammation driven by oxidative stress and metabolic dysfunction. Despite lifestyle interventions, effective pharmacological options remain limited. The thyroid hormone receptor-β selective agonist resmetirom was recently approved for moderate-to-advanced fibrotic MASH, but treatment gaps remain. Vitamin E, a natural antioxidant, has shown potential in reducing liver inflammation, yet its optimal dosing, long-term effects, and safety profile require further evaluation. Identifying a safe and effective Vitamin E dosage for MASH treatment could transform patient outcomes worldwide. Further research is needed to establish definitive treatment regimens. About the Study Minimal adverse effects with no safety red flags: Over 96 weeks, Vitamin E was well tolerated, with no reported cases of prostate cancer, cardiovascular events, or hemorrhagic stroke, addressing past concerns linked to high-dose Vitamin E. A multi-center, double-blind, randomized, placebo-controlled trial was conducted across 14 clinical centers in China. Participants diagnosed with biopsy-proven MASH were recruited and randomly assigned in a 1:1 ratio to receive either Vitamin E (300 mg per day) or placebo for 96 weeks. All participants received dietary and exercise recommendations throughout the study period. Baseline and post-treatment liver biopsies were centrally reviewed by independent hepatopathologists blinded to treatment allocation. The primary endpoint was histological improvement, defined as a reduction in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) by at least 2 points, with no worsening of fibrosis. The study followed a modified intention-to-treat (mITT) approach, with sensitivity analyses performed to confirm robustness. Secondary endpoints included fibrosis regression, resolution of steatohepatitis, and changes in liver enzymes, inflammatory markers, and metabolic parameters. FibroScan-based liver stiffness measurement (LSM) was also assessed to provide additional insights into fibrosis progression. Biochemical parameters were assessed at regular intervals, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), fasting plasma glucose, and pro-inflammatory cytokines (tumor necrosis factor-alpha [TNF-α] and interleukin-6 [IL-6]). Statistical analyses were conducted using SAS 9.4 and R 4.2.3, with Analysis of Covariance (ANCOVA) models used for continuous variables and logistic regression for binary outcomes. The study adhered to strict ethical guidelines, and all participants provided informed consent. Study Results Personalized lifestyle guidance was a key part of the trial: All participants received individualized diet and exercise recommendations, which were monitored through a mobile app, ensuring a consistent approach to lifestyle management alongside supplementation. A total of 124 participants were enrolled, with 58 in the Vitamin E group and 66 in the placebo group. Baseline characteristics, including age, gender distribution, and metabolic parameters, were comparable between groups. The mean age was approximately 38 years, with a predominance of male participants (72.4% in the Vitamin E group and 75.8% in the placebo group). A statistically significant 29.3% of participants receiving Vitamin E experienced histological improvement, compared to 14.1% in the placebo group (odds ratio [OR]: 2.5; 95% confidence interval [CI]: 1.0-7.1; p = 0.04). Subgroup analyses revealed greater improvement among males, participants under 40, and those with baseline NAS scores of 5-8. Fibrosis regression by at least one stage without worsening of steatohepatitis was observed in 25.9% of the Vitamin E group versus 15.6% in the placebo group, but this difference was not statistically significant (OR: 1.9; 95% CI: 0.7-5.2; p = 0.16). However, FibroScan liver stiffness measurement (LSM) showed a significant improvement in the Vitamin E group (p = 0.04), indicating potential long-term benefits despite biopsy-based fibrosis outcomes not reaching statistical significance. Steatohepatitis resolution without worsening of fibrosis was observed in 12.1% of the Vitamin E group compared to 17.2% in the placebo group (OR: 0.7; 95% CI: 0.2-2.0; p = 0.43). Despite this, significant reductions in steatosis (p = 0.01), lobular inflammation (p = 0.04), fibrosis score (p = 0.04), and total NAS score (p = 0.03) were observed in the Vitamin E group. Liver enzyme levels improved significantly in the Vitamin E group, with ALT and AST reductions of 20% and 18%, respectively. Serum pro-inflammatory cytokine levels, including TNF-α and IL-6, also showed significant r

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Posted March 5, 2025