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patients undergoing hip surgery; 75 failed to meet entry hematologic or medical criteria; 95 were randomized, with 16 withdrawn because of complications.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 [Cl] for difference of —6.6 to 5.4 g/L). Corrected reticulocyte fractions increased equally in both groups (95% Cl for difference of —9 × 103 to 2 × 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 × 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.(JAMA. 1992;267:525-527)