title: Intravenous iron and erythropoietin for anemia associated with Crohn disease. A randomized, controlled trial.
abstract: BACKGROUND
  Anemia often complicates Crohn disease and affects quality of life.
  
  
  OBJECTIVE
  To evaluate the efficacy of intravenous iron alone and in combination with erythropoietin for the treatment of anemia associated with Crohn disease.
  
  
  METHODS
  Double-blind, randomized, placebo-controlled trial with a subsequent open-label phase.
  
  
  METHODS
  University-based gastroenterology outpatient clinic.
  
  
  METHODS
  40 patients with Crohn disease and a hemoglobin concentration of 10.5 g/dL or less.
  
  
  METHODS
  All patients received intravenous iron saccharate for 16 weeks. During the blinded phase of the trial, they received either erythropoietin or placebo. During the open phase, the erythropoietin dose was increased in non-responders who had received erythropoietin and erythropoietin therapy was initiated in nonresponders who had received placebo.
  
  
  METHODS
  Response was defined as an increase in hemoglobin concentration of 2 g/dL or more.
  
  
  RESULTS
  15 of 20 patients in the placebo group (75% [95% CI, 51% to 91%]) and 18 of 19 patients in the erythropoietin group (95% [CI, 74% to 100%]) responded to intravenous iron (P = 0.20). The erythropoietin group had a higher cumulative response rate (P = 0.036) and a more pronounced mean increase in hemoglobin concentration (4.9 g/dL in the erythropoietin group compared with 3.3 g/dL in the placebo group, a difference of 1.6 g/dL [CI, 0.6 g/dL to 2.5 g/dL]; P = 0.004). In the open phase, all 6 previous nonresponders had a response. Hematologic response was associated with improved quality of life (P = 0.03).
  
  
  CONCLUSIONS
  Most patients who have anemia associated with Crohn disease respond to intravenous iron alone. Erythropoietin has additional effects on hemoglobin concentrations.
authors.affiliation: University of Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Gasché
authors.forename: C
authors.initials: C
authors.lastname: Dejaco
authors.forename: T
authors.initials: T
authors.lastname: Waldhoer
authors.forename: W
authors.initials: W
authors.lastname: Tillinger
authors.forename: W
authors.initials: W
authors.lastname: Reinisch
authors.forename: G F
authors.initials: GF
authors.lastname: Fueger
authors.forename: A
authors.initials: A
authors.lastname: Gangl
authors.forename: H
authors.initials: H
authors.lastname: Lochs
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D003424:Crohn Disease / Q000150:complications* / Q000523:psychology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D007501:Iron