Table 3.
Summary of clinical efficacy of pSS patients.
| JieDuTongLuoShengJin granules + HCQ | Placebo + HCQ | p value (between-group) | ||||
|---|---|---|---|---|---|---|
| Week 4 | Week 12 | Week 4 | Week 12 | Week 4 | Week 12 | |
| Dryness (0–10) | 0.118 | 0.026 | ||||
| Mean ± SD | 5.1 ± 2.17 | 3.6 ± 2.41 | 5.6 ± 2.28 | 5.2 ± 2.31 | ||
| Median (IQR) | 5.0 (3.0, 7.0) | 3.5 (1.8, 5.3) | 6.0 (4.8, 7.3) | 5.5 (4.5, 7.0) | ||
| p value versus week 0 | 0.049 | 0.011 | 0.214 | 0.124 | ||
| Fatigue (0–10) | 0.765 | 0.002 | ||||
| Mean ± SD | 5.2 ± 2.71 | 3.3 ± 2.00 | 5.3 ± 2.15 | 4.9 ± 1.98 | ||
| Median (IQR) | 5.0 (4.0, 7.3) | 3.0 (2.0, 5.0) | 5.0 (4.0, 7.0) | 5.0 (4.0, 6.3) | ||
| p value versus week 0 | 0.042 | 0.000 | 0.090 | 0.115 | ||
| Pain (0–10) | 0.853 | 0.322 | ||||
| Mean ± SD | 2.3 ± 1.98 | 1.5 ± 1.61 | 2.2 ± 2.43 | 1.7 ± 2.25 | ||
| Median (IQR) | 2.5 (0.0, 3.3) | 1.0 (0.0, 2.3) | 1.5 (0.0, 4.0) | 0.5 (0.0, 2.3) | ||
| p value versus week 0 | 0.034 | 0.006 | 0.025 | 0.014 | ||
| ESSPRI (0–10) | 0.217 | 0.002 | ||||
| Mean ± SD | 4.2 ± 1.60 | 2.8 ± 1.18 | 4.4 ± 1.72 | 3.9 ± 1.63 | ||
| Median (IQR) | 4.3 (2.7, 5.2) | 2.7 (2, 3.7) | 4.3 (3.7, 5.0) | 3.9 (3, 4.8) | ||
| p value versus week 0 | 0.009 | 0.000 | 0.039 | 0.032 | ||
| PGA (0–10) | 0.716 | 0.019 | ||||
| Mean ± SD | 5.0 ± 1.75 | 3.3 ± 1.68 | 5.4 ± 2.03 | 4.7 ± 2.01 | ||
| Median (IQR) | 5.0 (3.0, 6.3) | 3.0 (2.0, 5.0) | 5.0 (4.0, 7.0) | 5.0 (3.0, 6.0) | ||
| p value versus week 0 | 0.008 | 0.000 | 0.042 | 0.016 | ||
| Salivary flow rate (ml/15 min) | 0.613 | 0.321 | ||||
| Mean ± SD | 0.8 ± 0.71 | 1.1 ± 0.81 | 0.7 ± 0.55 | 0.9 ± 0.57 | ||
| Median (IQR) | 0.9 (0.2, 1.0) | 1.0 (0.6, 1.5) | 0.7 (0.3, 1.0) | 0.9 (0.8, 1.0) | ||
| p value versus week 0 | 0.085 | 0.000 | 0.354 | 0.049 | ||
| Schirmer's test (left) (mm/5 min) | 0.445 | 0.527 | ||||
| Mean ± SD | 4.7 ± 3.89 | 5.0 ± 4.44 | 3.9 ± 2.78 | 4.1 ± 2.44 | ||
| Median (IQR) | 3.0 (2.0, 5.3) | 4.0 (2.0, 5.3) | 3.0 (2.0, 5.0) | 3.3 (2.0, 6.0) | ||
| p value versus week 0 | 0.457 | 0.284 | 0.938 | 0.585 | ||
| Schirmer's test (right) (mm/5 min) | 0.543 | 0.759 | ||||
| Mean ± SD | 4.5 ± 2.67 | 5.0 ± 5.15 | 3.6 ± 1.96 | 4.1 ± 2.34 | ||
| Median (IQR) | 4.0 (3.0, 5.0) | 4.0 (2.0, 6.0) | 3.0 (2.0, 5.0) | 4.0 (2.0, 6.0) | ||
| p value versus week 0 | 0.561 | 0.948 | 0.202 | 0.114 | ||
| BUT (left) (second) | 0.527 | 0.928 | ||||
| Mean ± SD | 3.7 ± 1.87 | 3.9 ± 1.66 | 3.0 ± 1.43 | 3.6 ± 1.36 | ||
| Median (IQR) | 3.5 (2.0, 4.3) | 4.0 (2.8, 5.0) | 2.5 (2.0, 3.3) | 3.0 (2.8, 4.3) | ||
| p value versus week 0 | 0.717 | 0.663 | 0.776 | 0.108 | ||
| BUT (right) (second) | 0.474 | 0.873 | ||||
| Mean ± SD | 3.6 ± 1.38 | 3.6 ± 1.39 | 3.2 ± 1.15 | 3.4 ± 1.50 | ||
| Median (IQR) | 3.0 (3.0, 4.0) | 3.5 (3.0, 4.3) | 3.0 (2.0, 4.0) | 3.5 (2.0, 5.0) | ||
| p value versus week 0 | 0.490 | 0.479 | 0.763 | 0.299 | ||
| van Bijsterveld (left) (score) | 0.542 | 0.588 | ||||
| Mean ± SD | 3.2 ± 1.50 | 3.5 ± 1.93 | 3.5 ± 1.67 | 3.1 ± 1.80 | ||
| Median (IQR) | 3.0 (2.0, 4.0) | 3.5 (2.0, 5.0) | 3.0 (2.8, 4.3) | 3.0 (1.8, 4.3) | ||
| p value versus week 0 | 0.460 | 0.877 | 0.720 | 0.769 | ||
| van Bijsterveld (right) (score) | 0.800 | 0.631 | ||||
| Mean ± SD | 3.4 ± 1.60 | 3.4 ± 1.90 | 3.5 ± 1.67 | 3.2 ± 1.76 | ||
| Median (IQR) | 3.5 (2.8, 4.0) | 3.5 (2.0, 4.3) | 3.5 (2.8, 4.3) | 3.0 (2.0, 4.3) | ||
| p value versus week 0 | 0.482 | 0.456 | 0.550 | 0.919 | ||
| ESSDAI (0–124) | 0.790 | |||||
| Mean ± SD | 2.0 ± 1.10 | 1.8 ± 1.46 | ||||
| Median (IQR) | 2.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | ||||
| p value versus week 0 | 0.003 | 0.016 | ||||
| IgG (g/L) | 0.857 | |||||
| Mean ± SD | 16.7 ± 2.39 | 17.3 ± 5.77 | ||||
| Median (IQR) | 17.3 (15.3, 18.9) | 16.2 (14.7, 17.0) | ||||
| p value versus week 0 | 0.010 | 0.096 | ||||
| C3 (g/L) | 0.878 | |||||
| Mean ± SD | 1.0 ± 0.16 | 0.9 ± 0.18 | ||||
| Median (IQR) | 1.0 (0.9, 1.0) | 0.9 (0.8, 1.0) | ||||
| p value versus week 0 | 0.054 | 0.101 | ||||
| C4 (g/L) | 0.616 | |||||
| Mean ± SD | 0.2 ± 0.05 | 0.2 ± 0.05 | ||||
| Median (IQR) | 0.2 (0.2, 0.3) | 0.2 (0.2, 0.2) | ||||
| p value versus week 0 | 0.065 | 0.087 | ||||
| ESR (mm/h) | 0.371 | |||||
| Mean ± SD | 24.4 ± 16.15 | 26.1 ± 20.93 | ||||
| Median (IQR) | 22.0 (14.0, 31.0) | 21.5 (14.0, 30.5) | ||||
| p value versus week 0 | 0.001 | 0.049 | ||||
| CRP (mg/L) | 0.807 | |||||
| Mean ± SD | 3.3 ± 1.97 | 4.4 ± 5.91 | ||||
| Median (IQR) | 2.0 (1.9, 4.3) | 2.9 (1.8, 5.8) | ||||
| p value versus week 0 | 0.391 | 0.605 | ||||