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 2
Primary and secondary outcomes after 6 months’ intervention.
XLGB
Control
Estimated treatment difference, XLGB versus control (95% CI)
Knee OA
NPRS (0–10)
Change from baseline, mean (SD)
−0.96 (2.14)
0.93 (2.09)
1.89 (1.52, 2.25)
<0.001
50% decrease, number (%)
83 (36.1)
19 (8.5)
<0.001
20% decrease, number (%)
165 (71.7)
45 (20.1)
<0.001
WOMAC (0–96)
Total
Change from baseline, mean (SD)
−7.06 (13.67)
3.00 (12.98)
10.06 (7.86, 12.26)
<0.001
Pain subscale
Change from baseline, mean (SD)
−2.25 (4.03)
0.42 (3.83)
2.67 (2.02, 3.32)
<0.001
50% decrease, number (%)
55 (23.9)
12 (5.4)
<0.001
20% decrease, number (%)
136 (59.1)
42 (18.8)
<0.001
Stiffness subscale
Change from baseline, mean (SD)
−0.46 (1.44)
0.48 (1.42)
0.93 (0.69, 1.18)
<0.001
Function subscale
Change from baseline, mean (SD)
−4.35 (8.25)
2.09 (7.78)
6.44 (5.12, 7.76)
<0.001
50% decrease, number (%)
42 (18.3)
10 (4.5)
<0.001
20% decrease, number (%)
122 (53.0)
38 (17.0)
<0.001
Patients taking rescue medicine
Number (%)
13 (5.7)
50 (22.3)
<0.001
Hand OA
NPRS (0–10)
Change from baseline, mean (SD)
−0.50 (1.98)
0.40 (1.84)
0.90 (0.38, 1.90)
=0.001
50% decrease, number (%)
25 (27.5)
11 (12.2)
=0.010
20% decrease, number (%)
45 (49.5)
20 (22.2)
<0.001
AUSCAN (0–60)
Total
Change from baseline, mean (SD)
−4.60 (7.98)
2.16 (7.35)
6.76 (4.75, 8.77)
<0.001
Pain subscale
Change from baseline, mean (SD)
−1.61 (3.44)
1.01 (3.17)
2.61 (1.73, 3.50)
<0.001
50% decrease, number (%)
22 (24.2)
4 (4.4)
<0.001
20% decrease, number (%)
45 (49.5)
10 (11.1)
<0.001
Stiffness subscale
Change from baseline, mean (SD)
−0.18 (0.52)
0.12 (0.48)
0.30 (0.16, 0.44)
<0.001
Function subscale
Change from baseline, mean (SD)
−2.78 (4.10)
1.04 (3.83)
3.82 (2.76, 4.87)
<0.001
50% decrease, number (%)
11 (12.1)
3 (3.3)
=0.027
20% decrease, number (%)
44 (48.4)
10 (11.1)
<0.001
Patients taking rescue medicine
Number (%)
7 (7.7)
21 (23.3)
=0.004
Estimated differences in treatment effect are from an analysis of covariance with data from the ITT population, with last-observation-carried-forward (LOCF) imputation. The ITT population comprising patients who underwent randomization were exposed to at least one treatment dose. XLGB: Xianlinggubao herbal formula; OA: osteoarthritis; NPRS: numeric pain rating scale; WOMAC: Western Ontario and McMaster Universities Arthritis Index; AUSCAN: Australian/Canadian Osteoarthritis Hand Index.
