Oral iron supplementation after an acute nonvariceal upper gastrointestinal bleeding (UGIB) event elicits a hemoglobin response without increasing risk for adverse events. These findings, from an open-label, randomized controlled trial, were published in the Journal of Gastroenterology and Hepatology.
Patients (N=151) who presented with acute nonvariceal UGIB and anemia secondary to UGIB were enrolled for the trial). Patients were randomly assigned 1:1 to receive 600 mg/d ferrous fumarate (n=77) or standard care (n=74) for 6 weeks. The primary outcome was the rate of composite hemoglobin response at the end of treatment. Anemia was defined as hemoglobin lower than 12 g/dL for women, 13 g/dL for men, and hemoglobin response as 2 g/dL increase in hemoglobin and levels in the normal range.
The intervention and control cohorts had a mean [SD] age of 57.5[ 13.0] and 56.0[14.3] years; 77.6% and 85.1% were men; they had BMIs of 23.3[4.8] and 23.3[3.8] kg/m2; 45.5% and 32.4% had no comorbidities; and hemoglobin levels at baseline were 7.5[2.4] and 8.4[2.6] g/dL (P =.027), respectively.
The most common sources of UGIBs were peptic ulcer (82.4%-89.4%), gastritis (5.2%-8.1%), esophageal ulcer or erosive esophagitis (1.3%-5.4%), and Mallory-Weiss syndrome (2.7%-3.9%). Nearly half of participants (45.9%-48.1%) were diagnosed with Helicobacter pylori infections.
Of note, more of the intervention cohort received red blood cell infusion (81.8%) than controls (66.2%; P = .024).
The treatment adherence rates were high among both the intervention (88.3%) and control (93.2%) cohorts (P = .34).
Hemoglobin response was achieved by 72.7% of the iron supplement recipients compared with 45.9% of the usual care recipients. Iron supplementation associated with achieving hemoglobin response (adjusted effect size, 2.980; P =.004).
The iron supplementation intervention also associated with superior hemoglobin levels (mean, 11.8 vs 11.1 g/dL; P <.001), changes in hemoglobin levels (mean, 2.9 vs 1.7 g/dL; P <.001), percentage change in hemoglobin levels (34.2% vs 19.4%; P <.001), proportion of patients with ferritin below 30 mg/L (16.9% vs 52.7%; P <.001), and proportion of patients with transferrin saturation below 16% (32.5% vs 52.7%; P =.030) compared with controls, respectively.
The rates of treatment-associated adverse events were 20.8% among the iron supplement recipients and 14.9% among the control group (P = .31). The most common events included constipation (10.8%-16.9%), nausea (1.3%-2.7%), and loose stool (1.4%-2.6%).
The limitations of this study included the open-label design, the lack of a placebo control, and the cohort imbalances in baseline hemoglobin levels and receipt of blood transfusion.
These data indicated that post-UGIB iron supplementation improved hemoglobin response at 6 weeks. The study authors concluded, “This proof-of-concept study demonstrates that oral iron treatment effectively and rapidly increases hemoglobin levels in patients with UGIB without treatment-associated adverse effects. This may benefit patients who require a rapid increase in hemoglobin levels without red blood cell transfusion, such as older patients and patients with preexisting stroke or cardiovascular diseases that may be worsened by prolonged anemia.”
Chang A, Rugivarodum M, Pungpipattrakul N, et al. Role of oral iron supplementation for anemia secondary to acute nonvariceal upper gastrointestinal bleeding: a randomized controlled trial. J Gastroenterol Hepatol. Published online March 30, 2023. doi:10.1111/jgh.16185