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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
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Trials

ISSN: 1745-6215