Table 1.
Baseline characteristics of the subjects with knee OA*
|
Placebo (n = 220) |
DF‐HA 30 mg (n = 218) |
|
|---|---|---|
| Age, years | 62.4 ± 8.1 | 63.3 ± 8.7 |
| Sex, no, (%) male/female | 75 (34.1)/145 (65.9) | 75 (34.4)/143 (65.6) |
| BMI, kg/m2 | 25.61 ± 3.95 | 25.46 ± 3.75 |
| Duration of current pain, weeks | 268.3 ± 257.8 | 252.4 ± 262.0 |
| K/L grade, no. (%) | ||
| 2 | 124 (56.4) | 122 (56.0) |
| 3 | 96 (43.6) | 96 (44.0) |
| WOMAC pain score, mm† | 65.2 ± 7.6 | 64.9 ± 7.9 |
| WOMAC pain score category, no. (%)† | ||
| <70 mm | 163 (74.1) | 162 (74.3) |
| ≥70 mm | 57 (25.9) | 56 (25.7) |
| WOMAC stiffness score, mm† | 57.5 ± 21.4 | 56.6 ± 20.9 |
| WOMAC physical function score, mm† | 61.3 ± 12.8 | 59.8 ± 12.8 |
| WOMAC total score, mm† | 61.8 ± 11.0 | 60.6 ± 11.3 |
| 50‐foot walking test pain score, mm† | 68.0 ± 7.6 | 68.0 ± 8.5 |
| Daily pain score | 6.69 ± 1.20‡ | 6.60 ± 1.27 |
| Patient global assessment score, mm† | 70.1 ± 12.7 | 69.7 ± 12.9 |
| Physician global assessment score, mm† | 62.5 ± 14.1 | 62.9 ± 14.0 |
| SF‐36 summary score | ||
| MCS score | 55.8 ± 8.3 | 55.4 ± 8.1 |
| RCS score | 45.1 ± 13.0 | 47.2 ± 13.1 |
| PCS score | 25.8 ± 10.5 | 25.9 ± 11.6 |
| EQ‐5D | ||
| QOL score | 0.6778 ± 0.1354 | 0.6906 ± 0.1254 |
| VAS score | 66.3 ± 16.2 | 67.0 ± 16.3 |
| Daily acetaminophen dosage, mg/day | 220.5 ± 390.0 | 230.2 ± 399.5 |
*
Except where indicated otherwise, values are the mean ± SD. OA = osteoarthritis; DF‐HA = diclofenac etalhyaluronate; BMI = body mass index; K/L = Kellgren/Lawrence; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index; SF‐36 = Short Form 36; MCS = mental component summary; RCS = social role component summary; PCS = physical component summary; EQ‐5D = EuroQol 5‐domain; QOL = quality of life.
†
On a 100‐mm visual analog scale (VAS).
‡
Data were available for 219 patients.