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

Table 3

Summary of clinical efficacy of pSS patients.

	JieDuTongLuoShengJin granules + HCQ		Placebo + HCQ		value (between-group)
	Week 4	Week 12	Week 4	Week 12	Week 4	Week 12
Dryness (0–10)					0.118	0.026
Mean ± SD
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)
value versus week 0	0.049	0.011	0.214	0.124
Fatigue (0–10)					0.765	0.002
Mean ± SD
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)
value versus week 0	0.042	0.000	0.090	0.115
Pain (0–10)					0.853	0.322
Mean ± SD
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)
value versus week 0	0.034	0.006	0.025	0.014
ESSPRI (0–10)					0.217	0.002
Mean ± SD
Median (IQR)	4.3 (2.7, 5.2)	2.7 (2, 3.7)	4.3 (3.7, 5.0)	3.9 (3, 4.8)
value versus week 0	0.009	0.000	0.039	0.032
PGA (0–10)					0.716	0.019
Mean ± SD
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)
value versus week 0	0.008	0.000	0.042	0.016
Salivary flow rate (ml/15 min)					0.613	0.321
Mean ± SD
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)
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
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
value versus week 0		0.391		0.605