Clinical secondary outcomes between months 0 and 36 in the full analysis set (MAR-MMRM model)
Clinical outcomes changes between months 0 and 36 | Placebo (n=179) | ASU-E (n=166) | p Value* | Difference | 95% CI |
---|---|---|---|---|---|
Lequesne Index (normalised 0–100) | −0.14 (1.69) | 1.50 (1.78) | 0.506 | −1.63 (2.45) | −6.45 to 3.19 |
WOMAC pain (0–100 mm) | −0.98 (2.17) | −0.25 (2.33) | 0.818 | −0.73 (3.18) | −7.00 to 5.54 |
WOMAC stiffness (0–100 mm) | −2.29 (2.23) | −1.80 (2.43) | 0.881 | −0.49 (3.30) | −6.99 to 6.01 |
WOMAC function (0–100 mm) | 2.10 (2.13) | 1.48 (2.30) | 0.843 | 0.62 (3.13) | −5.55 to 6.79 |
Global hip pain on VAS (0–100 mm) | −3.60 (2.35) | −4.26 (2.51) | 0.849 | 0.66 (3.43) | −6.10 to 7.42 |
Global handicap on 0–10 scale | −0.21 (0.22) | −0.53 (0.24) | 0.326 | 0.32 (0.32) | −0.32 to 0.96 |
Patient's global assessment (0–100) | −4.25 (2.64) | −4.42 (2.84) | 0.963 | 0.18 (3.87) | −7.45 to 7.81 |
Values are mean (SEM).
*ANOVA treatment effect.
ASU-E, avocado–soybean unsaponifiable—Expanscience; MAR-MMRM, Missing at Random–Mixed Model for Repeated Measurements; VAS, visual analogue scale; WOMAC, Western and Ontario MacMaster University.