| 1 WOMAC pain (5 to 25 Likert) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.1 1 to 4 weeks post‐injection |
3 |
110 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.40 [‐2.85, ‐1.95] |
| 1.2 5 to 13 weeks post‐injection |
2 |
69 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.40 [‐6.92, ‐3.89] |
| 1.3 14 to 26 weeks post‐injection |
2 |
69 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.63 [‐6.08, ‐3.18] |
| 1.4 45 to 52 weeks post‐injection |
1 |
40 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.30 [‐7.02, ‐3.58] |
| 2 WOMAC pain (number of patients who improved) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 3 WOMAC pain (number of patients who achieved greater than 5 unit improvement (relative to baseline score)) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 3.1 14 to 26 weeks post‐injection |
1 |
135 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.42 [1.00, 2.02] |
| 4 Number of patients with a 20% improvement from baseline in WOMAC pain score |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 4.1 5 to 13 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.91, 1.44] |
| 4.2 14 to 26 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [0.94, 1.26] |
| 5 Number of patients with a 40% improvement from baseline in WOMAC pain score |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 5.1 5 to 13 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.30 [1.08, 1.57] |
| 5.2 14 to 26 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [1.00, 1.49] |
| 6 Number of patients with a 50% improvement from baseline in WOMAC pain score |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 6.1 5 to 13 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.99, 1.50] |
| 6.2 14 to 26 weeks post‐injection |
2 |
394 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.97, 1.54] |
| 7 WOMAC pain on standing (0 to 100 mm VAS; change from baseline) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 7.1 5 to 13 weeks post‐injection |
2 |
294 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.80 [‐9.76, 4.15] |
| 7.2 14 to 26 weeks post‐injection |
2 |
294 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.92 [‐10.22, 4.37] |
| 8 WOMAC physical function (17 to 85 Likert) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 8.1 1 to 4 weeks post‐injection |
3 |
110 |
Mean Difference (IV, Fixed, 95% CI) |
‐7.20 [‐8.84, ‐5.56] |
| 8.2 5 to 13 weeks post‐injection |
2 |
69 |
Mean Difference (IV, Fixed, 95% CI) |
‐12.87 [‐18.60, ‐7.14] |
| 8.3 14 to 26 weeks post‐injection |
2 |
69 |
Mean Difference (IV, Fixed, 95% CI) |
‐10.88 [‐16.97, ‐4.79] |
| 8.4 45 to 52 weeks post‐injection |
1 |
40 |
Mean Difference (IV, Fixed, 95% CI) |
‐7.10 [‐15.42, 1.22] |
| 9 Range of motion: flexion (degrees) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 9.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
4.0 [2.02, 5.98] |
| 10 25 metre walking time (sec) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 10.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
0.40 [‐0.40, 1.20] |
| 11 Knee circumference (mm) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 11.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.30 [‐0.73, 0.13] |
| 12 WOMAC stiffness (2 to 10 Likert) |
2 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 12.1 1 to 4 weeks post‐injection |
2 |
70 |
Mean Difference (IV, Random, 95% CI) |
‐0.93 [‐2.89, 1.02] |
| 12.2 5 to 13 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Random, 95% CI) |
‐1.5 [‐2.84, ‐0.16] |
| 12.3 14 to 26 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Random, 95% CI) |
‐1.5 [‐2.71, ‐0.29] |
| 13 WOMAC total score (0 to 100 mm VAS; change from baseline) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 13.1 5 to 13 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐7.80 [‐34.64, 19.04] |
| 13.2 14 to 26 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.38 [‐31.35, 22.60] |
| 14 Patient global assessment (0 to 100 mm VAS; where 100 is worst severity) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 14.1 1 to 4 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
‐20.0 [‐33.22, ‐6.78] |
| 14.2 5 to 13 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
‐20.0 [‐30.63, ‐9.37] |
| 14.3 14 to 26 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐12.77, 12.77] |
| 15 Patient global assessment (0 to 100 mm VAS; change from baseline) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 15.1 5 to 13 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.81 [‐10.11, 2.49] |
| 15.2 14 to 26 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.67 [‐10.07, 2.73] |
| 16 Patient global assessment (number patients rating treatment as effective or very effective) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 16.1 5 to 13 weeks post‐injection |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.2 [1.01, 4.79] |
| 17 Physician global assessment (0 to 100 mm VAS; where 100 is worst severity) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 17.1 1 to 4 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐17.62, 17.62] |
| 17.2 5 to 13 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐16.67, 16.67] |
| 17.3 14 to 26 weeks post‐injection |
1 |
29 |
Mean Difference (IV, Fixed, 95% CI) |
‐10.0 [‐26.50, 6.50] |
| 18 Physician global assessment (0 to 100 VAS; change from baseline) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 18.1 5 to 13 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.22 [‐9.48, 1.04] |
| 18.2 14 to 26 weeks post‐injection |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.08 [‐9.28, 1.12] |
| 19 Synovial fluid effusion volume (ml) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 19.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.0 [‐5.66, ‐2.34] |
| 20 Interleukin 6 level in the synovial fluid (pg/ml) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 20.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
‐11.90 [‐14.09, ‐9.71] |
| 21 Interleukin 8 level in the synovial fluid (pg/ml) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 21.1 1 to 4 weeks post‐injection |
1 |
43 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.80 [‐6.54, ‐3.06] |
| 22 Tumor necrosis factor alpha levels in synovial fluid |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 22.1 1 to 4 weeks post‐injection |
1 |
41 |
Mean Difference (IV, Fixed, 95% CI) |
‐9.30 [‐21.53, 2.93] |
| 23 Safety: total withdrawals overall |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 24 Safety: withdrawals due to lack of efficacy |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 25 Safety: number of patients with treatment related adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 26 Safety: number of patients withdrawn due to noncompliance |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 27 Safety: number of patients with reported musculoskeletal adverse events |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 28 Safety: number of patients with general body adverse events |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 29 Safety: number of patients with local skin rash |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 30 Safety: number patients with gastrointestinal complaints |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 31 Safety: number of patients with reported respiratory adverse events |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 32 Safety: number of patients with nervous system adverse events |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 33 Safety: number of patients with urinary adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 34 Safety: number of patients withdrawn due to local adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
