Table 5.
Comparison of the two-year change scores of HR-QoL between the two treatment groups with Analysis of Covariance (ANCOVA, intention-to-treat).
| Model 1 a | Model 2 (Fully Adjusted) b | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Two-Year Follow-up | Change Scores | Change Scores | |||||
| Median (IQR) | Median (IQR) | Mean Change (95% CI) | F | p | Mean Change (95% CI) | F | p | |
| SF-12 PCS (N = 2594) | 0.14 | 0.71 | 0.09 | 0.76 | ||||
| B-vitamins | 51.6 (44.5–54.3) | 51.1 (42.9–54.4) | −0.59 (−0.95, −0.23) | −0.60 (−0.95, −0.25) | ||||
| Placebo | 51.5 (43.5–54.6) | 50.8 (41.8–54.7) | −0.69 (−1.05, −0.32) | −0.68 (−1.03, −0.33) | ||||
| SF-12 MCS (N = 2594) | 0.14 | 0.71 | 0.18 | 0.67 | ||||
| B-vitamins | 57.2 (52.3–59.8) | 56.8 (51.8–59.8) | −0.52 (−0.89, −0.15) | −0.53 (−0.90, −0.16) | ||||
| Placebo | 56.8 (52.0–59.8) | 56.6 (51.2–59.8) | −0.42 (−0.79, −0.05) | −0.42 (−0.79, −0.04) | ||||
| EQ-5D Index (N = 2617) | 8.89 | 0.003 | 8.29 | 0.004 | ||||
| B-vitamins | 0.86 (0.81–1.00) | 0.89 (0.81–1.00) | 0.00 (−0.01, 0.01) | 0.00 (−0.01, 0.00) | ||||
| Placebo | 0.8 (0.81–1.00) | 0.84 (0.81–1.00) | −0.02 (−0.03, −0.01) | −0.02 (−0.03, −0.01) | ||||
| EQ-5D VAS (N = 2612) | 0.20 | 0.65 | 0.17 | 0.68 | ||||
| B-vitamins | 80 (75–90) | 80 (70–90) | −1.06 (−1.73, −0.39) | −1.07 (−1.73, −0.41) | ||||
| Placebo | 80 (75–90) | 80 (70–90) | −1.28 (−1.95, −0.61) | −1.27 (−1.93, −0.61) | ||||
a Adjusted for baseline values of the respective outcome variable; b additionally adjusted for age, sex, homocysteine, and study center. HR-QoL: health-related quality of life; SF-12: 12-item Short-Form Health Survey, PCS: Physical Component Summary score; MCS: Mental Component Summary score; EQ-5D: EuroQol 5 Dimensions; VAS: Visual Analogue Scale.