PRO-INFLAMMATORY | CCBT | RCBT | Difference | p2 |
CRP (mg/L) | Mean (SD)1 | Mean (SD) | Mean (95% CI) | |
Intention-to-treat analysis | ||||
Baseline (63 vs. 64)3 | 6.52 (6.64) | 5.92 (6.52) | 0.61 (−1.70 to 2.92) | 0.649 |
12-week (46 vs. 42) | 5.44 (6.67) | 7.88 (10.72) | −2.45 (−6.29 to 1.39) | 0.287 |
24-week (30 vs. 24) | 8.03 (10.75) | 8.09 (6.87) | −0.06 (−4.91 to 4.78) | 0.422 |
Per-protocol analysis | ||||
Baseline (43 vs. 46) | 6.64 (6.72) | 6.10 (6.40) | 0.54 (−2.23 to 3.30) | 0.624 |
12-week (43 vs. 39) | 5.34 (6.67) | 7.70 (10.6) | −2.36 (−6.32 to 1.60) | 0.665 |
24-week (28 vs. 22) | 8.11 (11.03) | 8.16 (6.94) | −0.05 (−5.20 to 5.10) | 0.410 |
TNF-α (pg/ml) | ||||
Intention-to-treat analysis | ||||
Baseline (63 vs. 61) | 6.92 (3.07) | 7.05 (3.76) | −0.13 (−1.35 to 1.09) | 0.842 |
12-week (44 vs. 42) | 6.81 (2.20) | 6.39 (2.46) | 0.42 (−0.58 to 1.41) | 0.286 |
24-week (29 vs. 27) | 6.46 (2.18) | 6.94 (5.01) | −0.48 (−2.60 to 1.65) | 0.847 |
Per-protocol analysis | ||||
Baseline (45 vs. 43) | 6.73 (2.31) | 6.27 (2.33) | 0.46 (−0.52 to 1.44) | 0.313 |
12-week (41 vs. 38) | 6.88 (2.24) | 6.30 (2.55) | 0.58 (−0.49 to 1.66) | 0.172 |
24-week (27 vs. 24) | 6.56 (2.23) | 6.85 (5.27) | −0.29 (−2.65 to 2.07) | 0.613 |
IL-1β (pg/ml) | ||||
Intention-to-treat analysis | ||||
Baseline (62 vs. 62) | 1.28 (1.07) | 1.71 (1.89) | −0.43 (−0.98 to 0.12) | 0.570 |
12-week (44 vs. 43) | 1.31 (1.11) | 1.25 (1.14) | 0.06 (−0.42 to 0.54) | 0.245 |
24-week (29 vs. 27) | 1.41 (1.93) | 1.17 (1.21) | 0.25 (−0.61 to 1.10) | 0.302 |
Per-protocol analysis | ||||
Baseline (44 vs. 44) | 1.11 (0.91) | 1.46 (1.44) | −0.34 (−0.85 to 0.17) | 0.728 |
12-week (40 vs. 39) | 1.28 (1.14) | 1.30 (1.18) | −0.03 (−0.54 to 0.49) | 0.360 |
24-week (27 vs. 24) | 1.42 (2.00) | 1.19 (1.28) | 0.23 (−0.71 to 1.17) | 0.318 |
IFN-γ (pg/ml) | ||||
Intention-to-treat analysis | ||||
Baseline (64 vs. 62) | 9.91 (8.12) | 9.41 (9.11) | 0.50 (−2.54 to 3.54) | 0.434 |
12-week (44 vs. 42) | 9.27 (7.65) | 9.22 (8.40) | 0.05 (−3.39 to 3.49) | 0.381 |
24-week (29 vs. 27) | 7.90 (5.46) | 7.07 (5.58) | 0.84 (−2.12 to 3.80) | 0.241 |
Per-protocol analysis | ||||
Baseline (45 vs. 44) | 8.45 (6.76) | 9.04 (9.01) | −0.59 (−3.94 to 2.76) | 0.694 |
12-week (41 vs. 38) | 8.94 (6.78) | 9.57 (8.74) | −0.63 (−4.12 to 2.87) | 0.421 |
24-week (27 vs. 24) | 8.28 (5.46) | 7.34 (5.81) | 0.95 (−2.23 to 4.12) | 0.209 |