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Table 2 Clinical and laboratory measures in the three groups over 2 years in intention-to-treat (ITT) analysis and per-protocol (PP) analysis

From: Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study

Variables Baseline Year 2
ITT PP
MTX (n = 69) TwFH (n = 69) TwFH + MTX (n = 69) MTX (n = 69) TwFH (n = 69) TwFH + MTX (n = 69) P MTX (n = 14) TwFH (n = 11) TwFH + MTX (n = 22) P
ESR (mm/h) 54.0 (28.0) 45.1 (24.6) 51.6 (25.9) 27.7 (22.6) 21.9 (17.9) 26.7 (27.3)   20.6 (16.8) 19.8 (19.0) 22.7 (26.4)  
mean (SD) 54.0 (28.3, 77.0) 38.0 (26.0, 67.0) 48.2 (31.0, 72.0) 23.0 (10.0, 34.8) 15.0 (9.0, 31.0) 17.5 (9.0, 34.8) 0.760 17.0 (8.0, 27.3) 12.0 (5.0, 28.0) 15.5 (6.0, 28.5) 0.868
median (IQR)
CRP (mg/L)
mean (SD) 37.5 (40.4) 27.3 (25.0) 30.1 (28.7) 20.6 (34.6) 11.3 (20.7) 14.7 (28.6)   9.0 (18.4) 15.2 (37.7) 9.8 (20.3)  
median (IQR) 21.7 (8.0, 53.8) 17.9 (7.0, 38.4) 24.8 (9.5, 42.6) 5.9 (1.4, 20.0) 3.5 (1.0, 12.7) 4.0 (2.0, 19.4) 0.803 1.7 (0.7, 9.4) 2.4 (0.7, 5.6) 3.7 (1.2, 9.1) 0.375
VAS (mm)
mean (SD) 71.4 (22.4) 68.5 (25.5) 70.5 (21.3) 36.8 (28.7) 32.1 (27.5) 36.7 (27.4)   33.2 (31.0) 29.1 (30.8) 33.6 (25.5)  
median (IQR) 72.5 (50.0, 90.0) 70.0 (50.0, 95.0) 75.0 (50.0, 85.0) 30.0 (10.0, 57.5) 20.0 (10.0, 50.0) 32.5 (15.0, 60.0) 0.674 30.0 (7.5, 55.0) 20.0 (0, 50.0) 32.5 (7.5, 60.0) 0.966
PGA (mm)
mean (SD) 68.0 (24.6) 65.5 (23.6) 65.8 (21.3) 37.7 (27.5) 32.7 (27.6) 38.8 (25.9)   33.6 (27.6) 21.8 (24.4) 35.7 (25.7)  
median (IQR) 70.0 (50.0, 87.5) 60.0 (50.0, 87.5) 62.5 (50.0, 80.0) 30.0 (10.0, 57.5) 25.0 (10.0, 50.0) 40.0 (18.8, 60.0) 0.959 30.0 (10.0, 50.0) 20.0 (0, 30.0) 37.5 (10.0, 60.0) 0.373
PhGA (mm)
mean (SD) 62.8 (23.5) 60.0 (23.7) 60.7 (23.1) 34.2 (27.7) 31.0 (26.6) 34.8 (26.1)   31.4 (32.3) 26.4 (26.9) 34.5 (26.8)  
median (IQR) 65.0 (43.5, 80.0) 60.0 (40.0, 80.0) 60.0 (45.0, 80.0) 30.0 (10.0, 60.0) 20.0 (10.0, 50.0) 30.0 (10.0, 51.3) 0.826 30.0 (3.8, 55.0) 20.0 (0, 50.0) 32.5 (10.0, 60.0) 0.701
TJC
mean (SD) 16.2 (8.3) 13.8 (7.2) 15.5 (8.3) 6.9 (7.1) 4.5 (5.8) 6.3 (7.5)   6.1 (6.3) 2.5 (3.4) 0.9 (1.4)  
median (IQR) 16.0 (7.5, 23.5) 13.0 (7.5, 17.0) 14.0 (8.0, 22.3) 5.0 (2.0, 10.0) 2.0 (0, 7.0) 3.0 (1.0, 9.0) 0.287 3.0 (1.0, 10.5) 2.0 (0, 5.0) 0 (0, 2.3) 0.368
SJC
mean (SD) 9.1(6.0) 8.9 (6.1) 8.9 (6.7) 2.9 (4.4) 2.5 (4.3) 2.4 (4.6)   3.1 (4.5) 0.3 (0.6) 2.2 (4.2)  
median (IQR) 7.0 (4.5, 13.0) 7.0 (4.0, 12.0) 7.0 (3.0, 11.3) 2.0 (0, 4.0) 0 (0, 4.0) 0 (0, 3.0) 0.836 1.0 (0, 5.0) 0 (0, 0) 0 (0, 2.3) 0.191
HAQ
mean (SD) 1.5 (0.9) 1.3 (0.9) 1.4 (0.9) 1.2 (3.6) 0.5 (0.7) 0.6 (0.7)   2.6 (7.9) 0.4 (0.6) 0.6 (0.6)  
median (IQR) 1.5 (0.9, 2.3) 1.3 (0.6, 2.0) 1.5 (0.6, 2.1) 0.5 (0, 1.3) 0.1 (0, 0.9) 0.4 (0, 1.0) 0.162 0.1 (0, 0.9) 0(0, 0.9) 0.5 (0.1, 1.1) 0.286
SF36
mean (SD) 237.8 (127.0) 292.6 (155.3) 279.1 (153.4) 388.8 (138.4) 448.9 (152.8) 417.2 (146.9)   453.3 (78.3) 469.7 (70.4) 445.1 (74.6)  
median (IQR) 231.0 (143.8, 310.0) 269.3 (181.2, 406.4) 260.5 (163.5, 364.3) 397.5 (305.5, 489.5) 470.2 (351.3, 536.5) 411.8 (329.8, 507.3) 0.259 478.1 (373.6, 525.7) 493.3 (426.8, 509.7) 460.8 (397.8, 506.8) 0.609
DAS28
mean (SD) 6.62 (1.31) 6.22 (1.28) 6.38 (1.40) 4.16 (1.70) 3.54 (1.69) 3.95 (1.77)   3.82 (1.96) 2.83 (1.72) 3.58 (1.63)  
median (IQR) 6.66 (5.48, 7.60) 6.16 (5.37, 7.06) 6.26 (5.47, 7.37) 3.70 (3.05, 5.12) 3.49 (2.09, 4.86) 3.89 (2.51, 5.13) 0.298 3.45 (2.71, 5.52) 2.40 (1.42, 4.49) 3.53 (2.01, 4.63) 0.613
  1. ESR erythrocyte sedimentation rate, CRP C-reactive protein, PGA Patient’s global assessment of disease activity, PhGA Physician’s global assessment of disease activity, TJC tender joint count, SJC swollen joint count, HAQ Health Assessment Questionnaire, SF-36 36-item Short-Form Health Survey questionnaire, DAS28 28-joint count Disease Activity Score, MTX methotrexate, TwHF Tripterygium wilfordii Hook F
  2. Data are presented as mean (standard deviation, SD) and median (interquartile range, IQR)
  3. The p values were calculated using the χ2 test