Table 7.
Placebo comparison results.
| Time | Arthrum 2.5% |
IA Placebo |
Difference (SD) | Effect size (95% CI) | P value | |||
|---|---|---|---|---|---|---|---|---|
| Variation/0 d (SD) | N | Variation/0 d (SD) | n | |||||
| WOMAC A | 30 | 22.3 (20.0) | 207 | 17.9 (19.6) | 326 | 4.39 (19.8) | 0.22 (0.05 to 0.39) | 0.013 |
| Pain (base 100) | 60 | 28.9 (17.4) | 199 | 22.2 (21.7) | 326 | 6.70 (20.2) | 0.33 (0.15 to 0.51) | < 0.001 |
| 90* | 30.7 (17.8) | 180 | 19.2 (24.3) | 326 | 11.49 (22.3) | 0.52 (0.34 to 0.70) | < 0.001 | |
| 180 | 33.6 (17.4) | 183 | 21.0 (21.2) | 198 | 12.61 (19.5) | 0.65 (0.45 to 0.85) | < 0.001 | |
| WOMAC C | 60 | 23.4 (17.3) | 181 | 21.3 (18.4) | 198 | 2.09 (17.9) | 0.12 (–0.08 to 0.32) | 0.26 |
| Function (base 100) | 90* | 25.6 (17.0) | 160 | 19.4 (19.0) | 198 | 6.17 (18.1) | 0.34 (0.13 to 0.55) | 0.001 |
| 180 | 27.6 (17.5) | 165 | 18.0 (21.6) | 198 | 9.57 (19.8) | 0.48 (0.27 to 0.69) | < 0.001 | |
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.
⁎
Results for Arthrum 2.5% (LCA Pharmaceutical, Chartres, France) obtained at 120 days have been used in the comparison at 90 days with placebo, as justified from the stability of the measures (see Figure 6).