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.”
References:
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