A randomized trial of iron depletion in patients with nonalcoholic fatty liver disease and hyperferritinemia

Figure 1 Study flow chart. NAFLD: Nonalcoholic fatty liver disease.

Figure 2 Effect of treatment on iron status and erythropoiesis. Effect of treatment on the levels of ferritin (A), transferrin saturation (B), and hemoglobin (C). Phlebotomy: dashed lines and black squares; Lifestyle changes alone: continuous lines and empty squares. ^aP < 0.05, ^bP < 0.01 between phlebotomy and lifestyle changes alone treatment arms.

Figure 3 Effect of treatment on liver damage. Prevalence of demonstrated histological improvement of liver damage at 2 years (any improvement in NAS score without worsening of fibrosis stage; main outcome of the study) in all patients who underwent randomization (panel A; n = 38; intention to treat analysis), and in patients compliant to the study protocol [panel B; n = 21 (19 biopsied and 2 failures due to serious adverse events), per protocol analysis]. The effect of treatment on overall liver damage assessment [improvement in liver histology or alanine aminotransferases (ALT) decrease ≥ 20% at the end of the study (n = 35, three patients could not be assessed because lost to final follow-up evaluation); direct and indirect analysis of liver damage evolution in all patients that completed follow-up] is shown in panel C.

Figure 4 Variations in histological indices of liver damage activity in individual patients subdivided according to treatment arm. A: Steatosis grade (P = 0.02 at Wilcoxon signed-rank test); B: Necroinflammation (P > 0.05); C: Ballooning (P > 0.05).

Figure 5 Effect of treatment on liver enzymes. Time course of liver enzymes: alanine aminotransferases (ALT, A), aspartate aminotransferases (AST, B), and gamma-glutamyl-transferases (GGT, C) during the study. Phlebotomy: Dashed lines and black squares; Lifestyle changes alone: Continuous lines and empty squares. ^aP < 0.05 between phlebotomy and lifestyle changes alone treatment arms.