Effects of dietary iron reduction versus phlebotomy in patients with chronic hepatitis C: results from a randomized, controlled trial on 40 Japanese patients.

BACKGROUND AND AIM Iron may play an important role in the pathogenesis of hepatitis C. We conducted this randomized, controlled trial comparing phlebotomy with dietary iron reduction. METHODS Forty patients with chronic hepatitis C showing serum ferritin levels of over 150 ng/ml were randomized to either group A (low-iron diet for six months) or group B (phlebotomy biweekly). Phlebotomy was continued until serum ferritin had reached 20 ng/ml or less. RESULTS At enrollment the clinical characteristics of patients in the two groups were similar. Serum ALT levels were significantly reduced in both groups, but the percent change in alanine aminotransferase (ALT) was larger in group B (median, -47.1 [range, -69.1 to -16.7] %) than in group A (-24.2 [-72.6 to 15.9] %, p<0.001). In group A subjects, no correlation was detected between percent change in ALT and clinical parameters. In group B subjects, the baseline ALT activity was significantly correlated with percent change in ALT (p<0.05), but iron-related parameters were not correlated. CONCLUSION The efficacy of phlebotomy is superior to that of dietary iron reduction in chronic hepatitis C. Serum levels of transaminase activities were a better indicator for phlebotomy than conventional indices of iron overload.