Intention-to-treat analysis of the changes from baseline to 12 weeks in the iron and placebo groups
| Variable | Mean change (adjusted)* (SD) | Treatment effect, ‡mean change (adjusted), (95% CI) | |
|---|---|---|---|
| Iron† n = 102 | Placebo n = 96 | ||
| Fatigue | |||
| Fatigue score (CAPPS; 0–40 points) | |||
| Effect on score | −12.2 (10.2) | −8.7 (11.7) | −3.46 (−6.7 to −0.3) |
| Change over time, % | −47.7 (35.6) | −28.8 (57.1) | −18.9 (−34.5 to −3.2) |
| Global fatigue index (MAF; 0–50 points) | |||
| Effect on score | −16.2 (11.8) | −11.2 (10.8) | −4.0 (−7.6 to −0.4) |
| Change over time, % | −41.3 (30.5) | −30.8 (27.6) | −10.5 (−19.2 to −1.9) |
| Severity index of fatigue (MAF; 0–10 points) | |||
| Effect on score | −3.6 (2.5) | −2.7 (2.3) | −0.87 (−1.5 to −0.08) |
| Change over time, % | −43.3 (30.1) | −33.6 (27.5) | −9.7 (−18.1 to −1.2) |
| Blood characteristics | |||
| Hemoglobin, g/dL | 0.28 (0.79) | −0.05 (0.83) | 0.32 (0.11 to 0.52) |
| Ferritin, μg/L | 11.6 (13.7) | 0.2 (11.0) | 11.4 (7.5 to 15.3) |
| Red blood cells, × 1012/L | 0.01 (0.19) | −0.02 (0.21) | 0.02 (−0.06 to 0.10) |
| Mean corpuscular volume, fL | 1.4 (3.5) | −0.6 (3.2) | 1.9 (1.1 to 2.7) |
| Hematocrit, % | 0.7 (2.7) | −0.4 (2.5) | 1.0 (0.2 to 1.7) |
| Transferrin, g/L | −0.17 (0.49) | 0.02 (0.38) | −0.15 (−0.3 to −0.05) |
| Soluble transferrin receptor, mg/L | −0.66 (0.69) | −0.13 (0.51) | −0.54 (−0.8 to −0.28) |
| Transferrin saturation, % | 2.8 (14.2) | −0.9 (14.1) | 3.8 (0.1 to 7.6) |
| Mental disorders (CAPPS; 0–40 points) | |||
| Depression | −5.0 (6.5) | −4.9 (7.4) | 0.04 (−2.0 to 2.1) |
| Anxiety | −5.5 (9.0) | −3.5 (9.1) | −2.0 (−4.9 to 0.9) |
| Quality of life | |||
| SF–12 (0–100 points) | 8.8 (13.4) | 6.0 (12.9) | 2.8 (−1.2 to 6.8) |
| Physical score, SF–12 (0–50 points) | 5.4 (8.4) | 3.1 (6.8) | 2.3 (−0.4 to 5.0) |
| Mental score, SF–12 (0–50 points) | 3.5 (8.6) | 2.7 (8.4) | 0.7 (−1.2 to 2.6) |
| CAPPS total score, (0–120 points) | −21.3 (20.5) | −16.9 (21.4) | −4.4 (−11.2 to 2.4) |
Note: CAPPS = Current and Past Psychological Scale, CI = confidence interval, MAF = multidimensional assessment of fatigue scale, SD = standard deviation, SF-12 = short form Self-Reported Health Questionnaire.
↵* Mean differences between baseline and 12 weeks were adjusted for clustering effects at the physician level.
↵† Iron = prolonged-release ferrous sulfate (FeSO4).
↵‡ Generalized estimating equations were used to calculate the average least-squares mean between groups adjusted for baseline values and the clustering effect between physicians. A hot-deck method with 10 imputations was used to account for data that were missing and lost to follow-up.