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