Evidence-Based Complementary and Alternative Medicine

Research Article

Effectiveness of Traditional Chinese Medicine Compound JieDuTongLuoShengJin Granules Treatment in Primary Sjögren’s Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Table 1

Summary of demographics and characteristics at baseline of pSS patients.
 JieDuTongLuoShengJin granules + HCQPlacebo + HCQ value
Patients randomized, 2020 
Age (years)  0.857
 Mean ± SD 
 Median5253 
 Range(27, 69)(24, 68) 
Gender, (%)  1.000
 Male0 (0.00)1 (5.00) 
 Female20 (100.00)19 (95.00) 
Disease duration (years)  0.989
 Mean ± SD 
 Median (IQR)4.5 (2, 8.25)5 (3, 7.25) 
 Range(0.2, 20)(0.5, 15) 
Dryness (0–10)  0.907
 Mean ± SD 
 Median (IQR)5.5 (3, 7.25)5.5 (4.75, 8) 
Fatigue (0–10)  0.957
 Mean ± SD 
 Median (IQR)5 (3.75, 8.25)5 (4, 7.25) 
Pain (0–10)  0.678
 Mean ± SD 
 Median (IQR)3 (0, 4)2 (0, 4) 
ESSPRI (0–10)  0.939
 Mean ± SD 
 Median (IQR)5 (2.7, 6.4)4.3 (3.8, 5.9) 
PASS, (%)9 (45.00)11 (55.00)0.752
PGA (0–10)  0.624
 Mean ± SD 
 Median (IQR)6 (3, 7)6 (4, 7) 
ESSDAI (0–124)  0.655
 Mean ± SD 
 Median (IQR)3 (1, 4)2 (1, 4) 
Salivary flow rate (ml/15 min)  0.989
 Mean ± SD 
 Median (IQR)0.8 (0.1, 1.0)0.7 (0.2, 1.0) 
Schirmer’s test (left) (mm/5 min)  0.224
 Mean ± SD 
 Median (IQR)3.8 (2.0, 5.3)2.0 (1.0, 4.5) 
Schirmer’s test (right) (mm/5 min)  0.126
 Mean ± SD 
 Median (IQR)4.0 (2.0, 6.3)2.0 (1.0, 4.0) 
BUT (Left) (second)  0.140
 Mean ± SD3.6 ± 1.543.0 ± 1.69 
 Median (IQR)3.0 (3.0, 4.0)2.5 (2.0, 4.0) 
BUT (Right) (second)  0.633
 Mean ± SD3.4 ± 1.573.2 ± 1.39 
 Median (IQR)3.0 (2.8, 3.3)3.0 (2.0, 4.0) 
van Bijsterveld score (Left)  0.622
 Mean ± SD3.5 ± 1.883.2 ± 1.94 
 Median (IQR)4.0 (2.0, 5.0)3.0 (2.0, 4.0) 
van Bijsterveld score (Right)  0.695
 Mean ± SD3.0 ± 1.693.2 ± 1.51 
 Median (IQR)3.0 (2.0, 4.0)3.0 (2.8, 4.0)  
IgG (g/L)  0.596
 Mean ± SD18.3 ± 3.0719.2 ± 6.91 
 Median (IQR)17.8 (16.4, 20.8)17.3 (14.3, 20.5) 
C3 (g/L)  0.204
 Mean ± SD0.9 ± 0.200.8 ± 0.20 
 Median (IQR)0.9 (0.8, 1.0)0.9 (0.8, 1.0) 
C4 (g/L)  0.071
 Mean ± SD0.2 ± 0.050.2 ± 0.05 
 Median (IQR)0.2 (0.2, 0.2)0.2 (0.1, 0.2) 
ESR (mm/h)  0.871
 Mean ± SD35.9 ± 25.7434.4 ± 31.83 
 Median (IQR)36.5 (14.3, 46.3)23.5 (18.0, 40.3) 
CRP (mg/L)  0.756
 Mean ± SD3.4 ± 2.693.4 ± 2.81 
 Median (IQR)2.4 (2.1, 3.2)2.6 (1.7, 4.2) 
RF positive, (%)9 (45.0)7 (35.0)0.748
Autoantibodies   
 Anti-SSA14 (70.0)16 (80.0)0.716
 Anti-SSB4 (20.0)3 (15.0)1.000