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Table 2 Overview of the primary and secondary outcome measures and the absolute clinical outcome scores at baseline, week 2, week 6 and week 12 in the placebo and choline-stabilized orthosilicic acid (ch-OSA) group

From: A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis

 

Placebo (n = 79)

ch-OSA (n = 87)

Treatment difference at 12 weeks (95% CI)

P value

P value treatment x gender interaction

Baseline (mean ± SD)

Week 2 (mean ± SD)

Week 6 (mean ± SD)

Week 12 (mean ± SD)

Change week 12 − baseline (mean ± SD)

Baseline (mean ± SD)

Week 2 (mean ± SD)

Week 6 (mean ± SD)

Week 12 (mean ± SD)

Change week 12 − baseline (mean ± SD)

WOMAC total score (/100 mm)

43.1 ± 20.3

39.1 ± 21.3

32.7 ± 21.2

32.3 ± 23.9

−10.8 ± 20.5

40.9 ± 19.4

37.3 ± 20.9

29.5 ± 21.5

29.3 ± 22.9

−11.6 ± 15.8

0.8 (−4.8 to 6.4)

0.78

0.06

WOMAC pain score (/100 mm)

41.2 ± 20.3

36.6 ± 21.1

30.3 ± 21.1

29.7 ± 23.9

−11.5 ± 22.1

38.2 ± 19.8

34.7 ± 21.4

27.7 ± 21.8

26.1 ± 22.2

−12.1 ± 17.5

0.6 (−5.5 to 6.7)

0.85

0.07

WOMAC stiffness score (/100 mm)

45.3 ± 24.6

39.7 ± 24.3

32.7 ± 23.4

34.0 ± 25.0

−11.3 ± 24.2

44.0 ± 23.5

38.8 ± 23.1

30.5 ± 22.8

30.0 ± 24.9

−14.0 ± 19.5

2.7 (−4.0 to 9.4)

0.43

0.04

WOMAC function score (/100 mm)

43.4 ± 21.2

39.8 ± 21.8

33.4 ± 21.8

32.9 ± 24.3

−10.6 ± 20.8

41.4 ± 19.8

37.9 ± 21.2

29.9 ± 21.8

30.2 ± 23.6

−11.2 ± 16.5

0.6 (−5.1 to 6.3)

0.84

0.09

Subject Global Assessment (/100 mm)

49.4 ± 21.8

39.0 ± 19.9

33.4 ± 20.7

32.5 ± 22.7

−16.9 ± 24.3

50.1 ± 18.2

41.2 ± 22.4

33.5 ± 24.4

32.1 ± 24.5

−18.0 ± 22.7

1.2 (−6.0 to 8.4)

0.75

0.05

CTX-II/Creatinine (ng/mmol)

413.1 ± 189.6

-

-

528.0a ± 261.8

114.9 ± 174.7

430.4 ± 212.7

-

-

533.6a ± 263.2

103.2 ± 178.6

11.7 (−48.7 to 72.1)

0.70

-

COMP (U/L)

10.8 ± 2.8

-

-

11.3 ± 3.4

0.6 ± 2.9

10.7 ± 2.8

-

-

11.1 ± 2.8

0.4 ± 2.6

0.1 (−0.7 to 1.0)

0.75

-

Silicon (μg/L)

50.9 ± 33.6

-

-

65.4a ± 42.2

14.6 ± 40.9

59.9 ± 36.1

-

-

115.8 a, b ± 56.0

55.8 ± 52.1

41.2 (25.8 to 56.8)

0.0005

-

  1. asignificant difference from baseline within the group; bsignificant difference between groups (placebo versus ch-OSA); -: not applicable; Number of patients without outliers for CTX-II: placebo (n = 66), ch-OSA (n = 68); Number of patients without outliers for COMP: placebo (n = 74), ch-OSA (n = 80); Number of patients without outliers for Silicon: placebo (n = 69), ch-OSA (n = 75)
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BMC Musculoskeletal Disorders

ISSN: 1471-2474

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