Table 2

Mean changes (and 95% CI) from baseline to the endpoint (week 26, ie, 6 months after the end of treatment) in the ITT population for primary (WOMAC pain subscale) and secondary outcomes, including number (and percentages) of OARSI/OMERACT responders and of patients achieving MCII and PASS, with difference between groups and p value

GO-ON (n=217)Hyalgan (n=209)Differencep ValueEffect size*
WOMAC pain−22.9 (−25. 7 to −20.1)−18.4 (−21.3 to −15.5)−4.5 (−8.5 to −0.5)0.0210.21 (0.02 to 0.40)
WOMAC function−22.2 (−25.1 to −19.3)−15.4 (−18.2 to −12.7)−6.8 (−10.7 to −2.8)0.00040.32 (0.13 to 0.52)
WOMAC stiffness−21.0 (−24.3 to −17.7)−15.7 (−19.0 to −12.4)−5.3 (−10.0 to −0.6)0.0270.22 (0.02 to 0.41)
WOMAC total−22.2 (−25.0 to −19.4)−16.1 (−18.8 to −13.4)−6.2 (−10.0 to −2.3)0.0010.31 (0.11 to 0.50)
VAS pain−33.2 (−36.5 to −29.8)−26.7 (−30.0 to −23.4)−6.4 (−11.1 to −1.8)0.0040.26 (0.07 to 0.45)
Lequesne index−4.2 (−4.7 to −3.7)−3.0 (−3.5 to −2.5)−1.2 (−2.0 to −0.6)0.00020.34 (0.15 to 0.53)
ICOAP total−21.0 (−23.8 to −18.3)−17.9 (−20.8 to −15.1)−3.2 (−7.0 to 0.9)0.13
ICOAP constant−21.3 (−24.4 to −18.3)−16.9 (−19.8 to −14.0)−4.5 (−8.6 to 0.3)0.052
ICOAP intermittent−20.8 (−23.6 to −18.0)−18.8 (−21.9 to −15.8)−1.9 (−6.0 to 2.2)0.32
VAS patient global18.8 (15.1 to 22.5)14.3 (10.6 to 17.9)4.6 (−0.6 to 9.8)0.068
OARSI/OMERACT responders, n (%)159 (73.3%)122 (58.4%)37 (14.9%)0.001
MCII pain, n (%)153 (70.5%)122 (58.4%)31 (12.1%)0.009
PASS pain, n (%)125 (57.6%)102 (48.8%)23 (8.8%)0.069
MCII function, n (%)150 (69.1%)117 (56.0%)33 (13.1%)0.005
PASS function, n (%)137 (63.1%)97 (46.4%)40 (16.7%)0.0005
MCII patient global, n (%)113 (52.1%)92 (44.0%)21 (8.1%)0.096
PASS patient global, n (%)126 (58.1%)90 (43.1%)36 (15.0%)0.002
  • All indices and scores are on a natural 0–100 mm or normalised 0–100 scale, except the Lequesne index. Baseline values are reported in table 1.

  • * Effect size and 95% CI shown only for continuous variables and where p<0.05.

  • ICOAP, index of intermittent and constant osteoarthritis pain; ITT, intention-to-treat; MCII, minimum clinically important improvement; OARSI, Osteoarthritis Research Society International; OMERACT, outcome measures in rheumatology; PASS, patient acceptable symptom state; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities.