Research Article

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 TotalXLGBControl value

Number of subjects534272262
Age
 Mean (SD), y62.51 (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 less274 (51.3)136 (50.0)138 (52.7)0.730
 Middle school151 (28.3)77 (28.3)74 (28.2)
 High school or more109 (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
 Number454230224
 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
 Number1819190
 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.