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Table 4 Condition of the participants at end of the trial

From: A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis

Indications

FAS

PPS

TLHS 4.8 g

TLHS 3.6 g

TLHS 2.4 g

Placebo

TLHS 4.8 g

TLHS 3.6 g

TLHS 2.4 g

Placebo

Pain (VAS), cm, mean ± SD

2.62 ± 1.37**

3.31 ± 1.30**

3.64 ± 1.29

3.99 ± 1.42

2.48 ± 1.30**

3.24 ± 1.32*

3.62 ± 1.30

3.89 ± 1.45

Pain changes, cm, mean ± SD

−3.06 ± 1.95**

−2.37 ± 1.31**

−1.85 ± 1.51

−1.53 ± 1.70

−3.31 ± 1.87**

−2.44 ± 1.25*

−1.88 ± 1.51

−1.63 ± 1.74

Tender joint counts, n, mean ± SD

3.88 ± 3.73**

4.80 ± 3.24

4.24 ± 2.54*

5.63 ± 4.10

3.96 ± 3.89

4.80 ± 3.38

4.19 ± 2.53

5.67 ± 4.32

Tender joint changes, n, mean ± SD

−5.24 ± 3.54**

−3.68 ± 3.19

−3.12 ± 2.88

−3.61 ± 3.51

−5.66 ± 3.46

−3.81 ± 3.24

−3.21 ± 2.88

−3.96 ± 3.54

Swollen joint counts, n, mean ± SD

2.24 ± 2.09**

2.68 ± 1.82

3.03 ± 1.88

3.41 ± 2.49

2.30 ± 2.13

2.56 ± 1.77

3.02 ± 1.90

3.31 ± 2.47

Swollen joint changes, n, mean ± SD

−4.03 ± 3.58*

−3.15 ± 2.48

−2.17 ± 2.43

−2.78 ± 2.96

−4.38 ± 3.61*

−3.31 ± 2.43

−2.30 ± 2.37

−3.04 ± 3.01

Morning stiffness, min, mean ± SD

36.53 ± 24.69**

46.10 ± 26.57

50.14 ± 36.08

54.93 ± 41.78

35.00 ± 23.27**

45.56 ± 27.29

50.14 ± 36.67

55.21 ± 44.38

Morning stiffness changes, min, mean ± SD

−45.51 ± 34.71

−35.25 ± 21.40

−33.17 ± 28.42

−35.32 ± 42.23

−50.09 ± 33.56

−38.15 ± 19.96

−33.81 ± 28.70

−39.12 ± 43.33

Grip strength, mmHg, mean ± SD

47.68 ± 28.59

38.80 ± 24.49

40.58 ± 26.27

38.84 ± 25.12

47.14 ± 29.13

36.00 ± 23.63

39.63 ± 26.22

36.99 ± 25.07

Grip strength changes, mmHg, mean ± SD

11.57 ± 21.19**

6.27 ± 7.07

5.51 ± 10.01

3.97 ± 8.53

12.32 ± 22.21**

6.76 ± 6.98

5.70 ± 10.13

3.93 ± 8.75

Physician’s assessments, score, mean ± SD

2.65 ± 1.40**

3.32 ± 1.37

3.62 ± 1.34

3.79 ± 1.42

2.52 ± 1.34**

3.24 ± 1.37

3.62 ± 1.36

3.68 ± 1.45

Physician’s assessments changes, score, mean ± SD

−2.67 ± 1.91**

−2.02 ± 1.36

−1.45 ± 1.48

−1.51 ± 1.65

−2.92 ± 1.84**

−2.07 ± 1.30

−1.46 ± 1.49

−1.60 ± 1.71

HAQ, score, mean ± SD

10.31 ± 9.91

12.69 ± 11.05

11.36 ± 9.64

12.92 ± 11.35

11.19 ± 10.06

12.89 ± 11.25

11.65 ± 9.67

13.60 ± 11.64

HAQ changes, score, mean ± SD

−6.37 ± 8.60

−5.41 ± 6.98

−4.03 ± 5.60

−4.15 ± 7.90

−6.89 ± 8.89

−5.83 ± 7.13

−4.18 ± 5.64

−4.31 ± 8.13

RF, U/ml, mean ± SD

122.61 ± 194.75

60.55 ± 99.04

90.35 ± 160.68

64.88 ± 102.79

129.88 ± 203.21

63.42 ± 104.21

93.28 ± 165.28

67.93 ± 109.24

CRP, mg/dl, median ± IQR

12.63 ± 44.50

5.68 ± 10.62

5.48 ± 8.48

6.81 ± 15.15

14.05 ± 47.27

5.75 ± 11.03

5.78 ± 8.70

7.25 ± 16.20

ESR, mm/h, mean ± SD

21.24 ± 21.91

21.32 ± 24.15

22.95 ± 20.24

23.25 ± 19.66

20.69 ± 21.89

21.39 ± 25.25

23.75 ± 20.42

24.26 ± 20.56

Joint functional stage, I : II : III

22:37:0

14:44:1

16:40:3

20:37:2

21:32:0

14:39:1

16:38:3

19:32:1

Voltaren use : no use

3:56**

10:47**

20:38**

23:33

3:50**

9:45**

20:37

21:31

Frequency of Voltaren use, mean ± SD

7.40 ± 8.08**

17.80 ± 13.02**

22.03 ± 17.11**

39.32 ± 20.13

7.40 ± 8.08**

17.63 ± 13.35**

22.03 ± 17.11**

39.29 ± 20.34

Leflunomide use : no use

14:45

22:35

22:36

24:32

41:39

20:34

22:35

22:30

  1. FAS full analysis set, PPS per protocol set, VAS visual analog scale, HAQ Health Assessment Questionnaire, RF rheumatoid factor, CRP C-reactive protein, ESR erythrocyte sedimentation rate
  2. *P < 0.05 and **P < 0.01 versus the placebo group. There were 226 patients in these four groups. Ten patients dropped out before the first follow-up at 2 weeks. The other dropouts were included in this table using the last follow-up data as the final data