A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial
Table 1
Participant demographics and baseline characteristics.
Characteristics
Total
XLGB
Control
value
Number of subjects
534
272
262
Age
Mean (SD), y
62.51 (10.05)
62.40 (9.87)
62.63 (10.26)
0.793
≥60, number (%)
314 (58.8)
162 (59.6)
152 (58.0)
0.717
Gender
Female, number (%)
321 (60.1)
162 (59.6)
159 (60.7)
0.790
Residence
Urban, number (%)
259 (48.5)
136 (50.0)
123 (46.9)
0.480
Rural, number (%)
275 (51.5)
136 (50.0)
139 (53.1)
Education
Primary school or less
274 (51.3)
136 (50.0)
138 (52.7)
0.730
Middle school
151 (28.3)
77 (28.3)
74 (28.2)
High school or more
109 (20.4)
59 (21.7)
50 (19.1)
Current smoking, number (%)
122 (22.8)
64 (23.5)
55 (21.0)
0.481
Current alcohol consumption, number (%)
101 (18.9)
52 (19.1)
51 (19.5)
0.919
BMI
<25, number (%)
355 (66.5)
177 (65.1)
178 (67.9)
0.746
2530, number (%)
157 (29.4)
84 (30.9)
73 (27.9)
≥30, number (%)
22 (4.1)
11 (4.0)
11 (4.2)
Knee OA
Number
454
230
224
K-L grades
K-L 2, number (%)
212 (46.7)
111 (48.3)
101 (45.1)
0.664
K-L 3, number (%)
187 (41.2)
90 (39.1)
97 (43.3)
K-L 4, number (%)
55 (12.1)
29 (12.6)
26 (11.6)
NPRS, mean (SD)
4.85 (1.87)
4.83 (1.83)
4.87 (1.91)
0.819
WOMAC score
Total, mean (SD)
43.51 (13.81)
43.40 (13.31)
43.61 (14.33)
0.873
Pain subscale, mean (SD)
11.31 (3.64)
11.28 (3.50)
11.33 (3.78)
0.879
Stiffness subscale, mean (SD)
4.06 (1.58)
4.03 (1.48)
4.09 (1.67)
0.670
Function subscale, mean (SD)
28.14 (8.74)
28.10 (8.49)
28.19 (9.01)
0.911
Hand OA
Number
181
91
90
K-L grades
K-L 2, number (%)
121 (66.9)
58 (63.7)
63 (70.0)
0.663
K-L 3, number (%)
45 (24.9)
25 (27.5)
20 (22.2)
K-L 4, number (%)
15 (8.3)
8 (8.8)
7 (7.8)
NPRS, mean (SD)
4.55 (13.81)
4.57 (1.83)
4.52 (1.74)
0.853
AUSCAN score
Total, mean (SD)
27.51 (9.33)
27.70 (9.13)
27.32 (9.58)
0.784
Pain subscale, mean (SD)
9.23 (3.13)
9.25 (3.13)
9.20 (3.14)
0.910
Stiffness subscale, mean (SD)
1.96 (0.78)
1.95 (0.77)
1.98 (0.79)
0.788
Function subscale, mean (SD)
16.33 (5.81)
16.51 (5.75)
16.14 (5.90)
0.677
XLGB: Xianlinggubao herbal formula; BMI: body mass index; OA: osteoarthritis; K-L: Kellgren and Lawrence grade; NPRS: numeric pain rating scale; WOMAC: Western Ontario and McMaster Universities Arthritis Index; AUSCAN: Australian/Canadian Osteoarthritis Hand Index.