C. Gasche et al., INTRAVENOUS IRON AND ERYTHROPOIETIN FOR ANEMIA ASSOCIATED WITH CROHN-DISEASE - A RANDOMIZED, CONTROLLED TRIAL, Annals of internal medicine, 126(10), 1997, pp. 782-787
Background: Anemia often complicates Crohn disease and affects quality
of life. Objective: To evaluate the efficacy of intravenous iron alon
e and in combination with erythropoietin for the treatment of anemia a
ssociated with Crohn disease. Design: Double-blind, randomized, placeb
o-controlled trial with a subsequent open-label phase. Setting: Univer
sity-based gastroenterology outpatient clinic. Patients: 40 patients w
ith Crohn disease and a hemoglobin concentration of 10.5 g/dL or less.
Intervention: All patients received intravenous iron saccharate for 1
6 weeks. During the blinded phase of the trial, they received either e
rythropoietin or placebo. During the open phase, the erythropoietin do
se was increased in nonresponders who had received erythropoietin and
erythropoietin therapy was initiated in nonresponders who had received
placebo. Measurements: Response was defined as an increase in hemoglo
bin 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 res
ponse rate (P = 0.036) and a more pronounced mean increase in hemoglob
in 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 t
o 2.5 g/dL]; P = 0.004). in the open phase, all 6 previous nonresponde
rs had a response. Hematologic response was associated with improved q
uality of life (P = 0.03). Conclusions: Most patients who have anemia
associated with Crohn disease respond to intravenous iron alone. Eryth
ropoietin has additional effects on hemoglobin concentrations.