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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)