OBJECTIVE: To assess the efficacy of oral iron therapy in the recovery of patients' hemoglobin levels after major surgery. DESIGN: Randomized controlled trial. SETTING: Private orthopedic practice confined to one large community hospital. PATIENTS: One hundred seventy consecutive elderly patients undergoing hip surgery; 75 failed to meet entry hematologic or medical criteria; 95 were randomized, with 16 withdrawn because of complications. INTERVENTION: Thirty-seven patients received ferrous sulfate orally four times a day for the duration of their hospitalization. Forty-two patients who received no iron supplement served as the control group. MAIN OUTCOME MEASURES: Changes in hemoglobin levels and reticulocyte counts over the 2- to 3-week follow-up period. RESULTS: There was no significant difference in mean hemoglobin levels between the treatment and control groups (95% confidence interval [CI] for difference of -6.6 to 5.4 g/L). Corrected reticulocyte fractions increased equally in both groups (95% CI for difference of -9 x 10(3) to 2 x 10(-3). The study was designed to detect a difference in mean hemoglobin levels of 8.5 g/L or greater or a difference in mean reticulocyte fraction of 10 x 10(-3) between the two groups with a power of 0.80 at the .05 (two-sided) level of significance. CONCLUSION: The administration of oral iron supplements to elderly, healthy orthopedic patients postoperatively did not hasten the recovery of hemoglobin levels, provided adequate tissue iron stores were present.
RCT Entities:
OBJECTIVE: To assess the efficacy of oral iron therapy in the recovery of patients' hemoglobin levels after major surgery. DESIGN: Randomized controlled trial. SETTING: Private orthopedic practice confined to one large community hospital. PATIENTS: One hundred seventy consecutive elderly patients undergoing hip surgery; 75 failed to meet entry hematologic or medical criteria; 95 were randomized, with 16 withdrawn because of complications. INTERVENTION: Thirty-seven patients received ferrous sulfate orally four times a day for the duration of their hospitalization. Forty-two patients who received no iron supplement served as the control group. MAIN OUTCOME MEASURES: Changes in hemoglobin levels and reticulocyte counts over the 2- to 3-week follow-up period. RESULTS: There was no significant difference in mean hemoglobin levels between the treatment and control groups (95% confidence interval [CI] for difference of -6.6 to 5.4 g/L). Corrected reticulocyte fractions increased equally in both groups (95% CI for difference of -9 x 10(3) to 2 x 10(-3). The study was designed to detect a difference in mean hemoglobin levels of 8.5 g/L or greater or a difference in mean reticulocyte fraction of 10 x 10(-3) between the two groups with a power of 0.80 at the .05 (two-sided) level of significance. CONCLUSION: The administration of oral iron supplements to elderly, healthy orthopedic patients postoperatively did not hasten the recovery of hemoglobin levels, provided adequate tissue iron stores were present.
Authors: L T Goodnough; A Maniatis; P Earnshaw; G Benoni; P Beris; E Bisbe; D A Fergusson; H Gombotz; O Habler; T G Monk; Y Ozier; R Slappendel; M Szpalski Journal: Br J Anaesth Date: 2011-01 Impact factor: 9.166