Primary and secondary efficacy outcomes in per-protocol population
| Outcome | Chondroitin sulfate+glucosamine hydrochloride* | Celecoxib* | p Value† | Treatment differences‡ |
|---|---|---|---|---|
| WOMAC pain score (imputed data on per-protocol set) | ||||
| Baseline | 372.0±41.8 | 370.6±41.4 | ||
| 180 days | 185.8 (171.2 to 200.4) | 184.7 (169.8 to 199.6) | 0.92 | −1.1 (−22.0 to 19.8) |
| Change | −185.7 (−200.3 to −171.1) | −186.8 (−201.7 to −171.9) | ||
| WOMAC stiffness score | ||||
| Baseline | 130.2±35.0 | 129.5±37.2 | ||
| 180 days | 69.1 (63.3 to 74.8) | 65.8 (59.9 to 71.7) | 0.43 | −3.3 (−11.5 to 5.0) |
| Change | −60.4 (−66.1 to −54.7) | −63.7 (−69.6 to −57.8) | ||
| WOMAC function score | ||||
| Baseline | 1131.4±242.7 | 1111.6±267.8 | ||
| 180 days | 617.0 (570.8 to 663.2) | 595.8 (548.4 to 643.2) | 0.53 | −21.2 (−87.3 to 45.0) |
| Change | −504.4 (−550.6 to −458.2) | −525.6 (−573.0 to −478.3) | ||
| Huskisson's visual analogue scale | ||||
| Baseline | 72.8±15.1 | 73.5±15.1 | ||
| 180 days | 37.9 (34.7 to 41.0) | 37.6 (34.4 to 40.9) | 0.92 | −0.22 (−4.8 to 4.3) |
| Change | −35.1 (−38.3 to −31.9) | −35.3 (−38.6 to −32.1) | ||
| OMERACT-OARSI responder§ | 188 (79.7) | 175 (79.2) | 0.91 | |
| Joint swelling§ | 14 (5.9) | 10 (4.5) | 0.54 | |
| Joint effusion§ | 7 (3.0) | 9 (4.1) | 0.61 | |
| Consumption of rescue medication (days 120–180) | 31.0 (25.8 to 36.2) | 29.0 (23.6 to 34.3) | 0.58 | −2.1 (−9.5 to 5.4) |
| Patients’ global assessment of disease activity | ||||
| Baseline | 69.1±17.3 | 69.4±16.4 | ||
| 180 days | 38.3 (35.3 to 41.4) | 36.9 (33.8 to 40.0) | 0.51 | −1.5 (−5.8 to 2.9) |
| Change | −31.0 (−34.0 to −28.0) | −32.4 (−35.6 to −29.3) | ||
| Investigators’ global assessment of disease activity | ||||
| Baseline | 63.2±15.5 | 63.3±14.7 | ||
| 180 days | 35.3 (32.6 to 38.1) | 33.4 (30.6 to 36.2) | 0.33 | −1.9 (−5.8 to 2.0) |
| Change | −27.8 (−30.5 to −25.1) | −29.7 (−32.5 to −26.9) | ||
| Patients’ global assessment of response to therapy at 180 days | 36.8 (33.5 to 40.2) | 36.0 (32.6 to 39.5) | 0.74 | −0.8 (−5.6 to 4.0) |
| Investigators’ global assessment of response to therapy | 34.7 (31.6 to 37.9) | 33.8 (30.6 to 37.0) | 0.70 | −0.9 (−5.4 to 3.6) |
| EuroQol-5D | ||||
| Mobility | 1.5±0.03 | 1.5±0.03 | 0.16 | |
| Self-care | 1.2±0.03 | 1.2±0.03 | 0.94 | |
| Usual activities | 1.4±0.03 | 1.4±0.03 | 0.73 | |
| Pain/discomfort | 1.8±0.03 | 1.9±0.03 | 0.60 | |
| Anxiety/depression | 1.4±0.04 | 1.3±0.04 | 0.21 | |
| Visual analogue scale | 69.1±1.3 | 70.2±1.3 | 0.54 | |
*Continuous variables are mean±SD at baseline and MMRM model baseline adjusted least-square means (95% CI) for other measurements; ordinal variables are mean±SD.
†MMRM model p value of treatment effect.
‡MMRM model adjusted mean (95% CI).
§n (%) and Fisher's exact test p value.
MMRM, mixed models for repeated measurement; WOMAC, Western Ontario and McMaster osteoarthritis index.