Randomised controlled trial of intravenous versus oral iron in treatment of iron deficiency anaemia after variceal bleeding in patients with cirrhosis

Background and Aim: There is limited evidence on the optimal strategy to correct iron deficiency anaemia after an episode of variceal bleeding (VB) in patients with cirrhosis. We evaluated the efficacy and safety of intravenous iron in this setting compared to oral iron therapy. Methods: In this single-centre randomised controlled trial with superiority study design, eligible patients with cirrhosis with iron deficiency anaemia after VB were randomised to receive either intravenous iron (Ferric carboxymaltose, haemoglobin and weight-based dose calculation) or oral iron (Carbonyl iron, 100 mg elemental iron per day) for 3 months. The primary outcome was increase in haemoglobin in both arms at 3 months. Secondary outcomes included resolution of anaemia (haemoglobin>12g/dL), normalization of iron stores (ferritin>100ng/dl), liver-related outcomes and drug-related adverse events. Changes in quality of life were assessed using Chronic Liver Disease Questionnaire at baseline and at 3 months. Results: 92 patients (Oral arm n=44, IV arm n=48, mean age 46.3-year, 87%males) of predominant non-viral aetiology (alcohol, NASH and HBV related 50%,18%, 13% respectively) were included in this trial. Baseline characteristics including median CTP score 7.00 [IQR6.00, 9.00], median MELD score12.00 [ IQR 10.00, 17.00] and degree of anaemia (8.25 ± 1.06 gm/dl) were comparable. The mean increase in haemoglobin in intravenous and oral arms was 3.62±0.35gm/dl and 1.60± 0.35 gm/dl respectively at 3 months (p value <0.001). Resolution of anaemia was seen 47.9% and 18% in intravenous and oral arm (p value <0.009). Normalization of iron stores was seen in 84.6% and 21% in intravenous and oral arms respectively (p value <0.001). Liver -related adverse events were comparable. None of the patients developed serious drug-related adverse events. There was a significant improvement in quality of life in intravenous arm. Conclusion: Intravenous iron replacement is safe and more effective than oral iron in improving haemoglobin, iron stores and quality of life in patients with iron deficiency anaemia after VB.