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. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2

Comparison 20. Hylan G‐F 20 versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Pain on weight bearing (0‐100 mm VAS) 6   Mean Difference (IV, Random, 95% CI) Subtotals only
1.1 1 to 4 weeks post‐injection 6 481 Mean Difference (IV, Random, 95% CI) ‐12.54 [‐20.39, ‐4.69]
1.2 5 to 13 weeks post‐injection 5 385 Mean Difference (IV, Random, 95% CI) ‐22.46 [‐35.24, ‐9.68]
1.3 14 to 26 weeks post‐injection 4 301 Mean Difference (IV, Random, 95% CI) ‐20.70 [‐35.56, ‐5.83]
2 Pain walking (0‐100 mm VAS) 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.1 1 to 4 weeks post‐injection 2 124 Mean Difference (IV, Fixed, 95% CI) ‐3.96 [‐9.01, 1.10]
2.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐13.80 [‐19.74, ‐7.86]
3 WOMAC pain 3   Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only
3.1 1 to 4 weeks post‐injection 2 60 Std. Mean Difference (IV, Fixed, 95% CI) ‐1.26 [‐1.86, ‐0.66]
3.2 5 to 13 weeks post‐injection 3 170 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.69 [‐1.02, ‐0.36]
3.3 14 to 26 weeks post‐injection 1 30 Std. Mean Difference (IV, Fixed, 95% CI) ‐1.09 [‐1.92, ‐0.25]
4 Pain at night (0‐100 mm VAS) 6   Mean Difference (IV, Fixed, 95% CI) Subtotals only
4.1 1 to 4 weeks post‐injection 6 391 Mean Difference (IV, Fixed, 95% CI) ‐8.03 [‐11.95, ‐4.12]
4.2 5 to 13 weeks post‐injection 5 295 Mean Difference (IV, Fixed, 95% CI) ‐14.47 [‐18.57, ‐10.38]
4.3 14 to 26 weeks post‐injection 3 182 Mean Difference (IV, Fixed, 95% CI) ‐17.12 [‐23.22, ‐11.02]
5 Pain at rest (0‐100 mm VAS) 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
5.1 1 to 4 weeks post‐injection 2 124 Mean Difference (IV, Fixed, 95% CI) ‐9.44 [‐14.07, ‐4.82]
5.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐18.67 [‐23.32, ‐14.02]
6 Pain overall (0‐100 mm VAS) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
6.1 1 to 4 weeks post‐injection 1 94 Mean Difference (IV, Fixed, 95% CI) ‐2.0 [‐13.09, 9.09]
7 WOMAC physical function 3   Mean Difference (IV, Fixed, 95% CI) Subtotals only
7.1 1 to 4 weeks post‐injection 2 60 Mean Difference (IV, Fixed, 95% CI) ‐7.09 [‐10.62, ‐3.56]
7.2 5 to 13 weeks post‐injection 3 170 Mean Difference (IV, Fixed, 95% CI) ‐11.91 [‐15.06, ‐8.76]
7.3 14 to 26 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐17.0 [‐26.90, ‐7.10]
8 Lequesne Index (0‐24) 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
8.1 5 to 13 weeks post‐injection 1 110 Mean Difference (IV, Fixed, 95% CI) ‐1.60 [‐2.98, ‐0.22]
8.2 14 to 26 weeks post‐injection 1 154 Mean Difference (IV, Fixed, 95% CI) 0.10 [‐1.38, 1.58]
9 Function: improvment in most painful knee movement (0‐100 mm VAS) 4   Mean Difference (IV, Fixed, 95% CI) Subtotals only
9.1 1 to 4 weeks post‐injection 4 267 Mean Difference (IV, Fixed, 95% CI) 19.29 [12.26, 26.31]
9.2 5 to 13 weeks post‐injection 4 263 Mean Difference (IV, Fixed, 95% CI) 33.25 [26.18, 40.31]
10 15 metre walking time 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
10.1 1 to 4 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) 0.80 [‐0.61, 2.21]
10.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐0.87 [‐2.52, 0.78]
11 WOMAC stiffness (2 to 10 Likert) 2   Mean Difference (IV, Fixed, 95% CI) Subtotals only
11.1 1 to 4 weeks post‐injection 2 60 Mean Difference (IV, Fixed, 95% CI) ‐1.08 [‐1.73, ‐0.44]
11.2 5 to 13 weeks post‐injection 2 60 Mean Difference (IV, Fixed, 95% CI) ‐1.34 [‐2.13, ‐0.55]
11.3 14 to 26 weeks post‐injection 1 39 Mean Difference (IV, Fixed, 95% CI) ‐1.0 [‐1.89, ‐0.11]
12 Patient global assessment (0‐100 mm VAS; where 100 is worst severity) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
12.1 1 to 4 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐20.0 [‐33.16, ‐6.84]
12.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐20.0 [‐30.57, ‐9.43]
12.3 14 to 26 weeks post injection 1 30 Mean Difference (IV, Fixed, 95% CI) 0.0 [‐12.68, 12.68]
13 Patient global assessment (number of patients good or very good) 5 to 13 weeks post‐injection 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
14 Patient global evaluation of efficacy due to treatment 5   Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only
14.1 1 to 4 weeks post‐injection 5 298 Std. Mean Difference (IV, Fixed, 95% CI) 0.70 [0.46, 0.93]
14.2 5 to 13 weeks post‐injection 5 295 Std. Mean Difference (IV, Fixed, 95% CI) 1.23 [0.97, 1.48]
15 Physician global assessment (0‐100 mm VAS; where 100 is worst severity) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
15.1 1 to 4 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐20.0 [‐37.64, ‐2.36]
15.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐20.0 [‐36.10, ‐3.90]
15.3 14 to 26 weeks post injection 1 30 Mean Difference (IV, Fixed, 95% CI) ‐10.00 [‐26.38, 6.38]
16 Number of survivors (patients not requiring additional treatment for study knee) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
16.1 45 to 52 weeks post‐injection 1 152 Risk Ratio (M‐H, Fixed, 95% CI) 1.33 [0.87, 2.01]
17 Number of clinical failures 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
17.1 14 to 26 weeks post‐injection 1 152 Risk Ratio (M‐H, Fixed, 95% CI) 0.66 [0.23, 1.87]
17.2 45 to 52 weeks post‐injection 1 118 Risk Ratio (M‐H, Fixed, 95% CI) 0.84 [0.59, 1.22]
18 Need for paracetamol (pill count) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
18.1 1 to 4 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
18.2 5 to 13 weeks post‐injection 1 30 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
19 Safety: total withdrawals overall 6   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
19.1 1 to 4 weeks post‐injection 1 94 Risk Ratio (M‐H, Fixed, 95% CI) 0.70 [0.12, 3.97]
19.2 5 to 13 weeks post‐injection 4 329 Risk Ratio (M‐H, Fixed, 95% CI) 1.40 [0.64, 3.06]
19.3 14 to 26 weeks post‐injection 1 52 Risk Ratio (M‐H, Fixed, 95% CI) 0.63 [0.24, 1.66]
20 Safety: number of patients withdrawn due to noncomplinance 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
21 Safety: number of patients with local reaction 6   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
22 Safety: number of patients with local adverse reactions but study drug continued 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
22.1 1 to 4 weeks post‐injection 1 30 Risk Ratio (M‐H, Fixed, 95% CI) 3.0 [0.13, 68.26]
23 Safety: number of patients with one or more probable or possible related systemic adverse events 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
23.1 5 to 13 weeks post‐injection 1 104 Risk Ratio (M‐H, Fixed, 95% CI) 1.98 [0.79, 4.96]
24 Safety: number of patients reporting systemic reactions 3   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
24.1 5 to 13 weeks post‐injection 3 219 Risk Ratio (M‐H, Fixed, 95% CI) 7.36 [0.39, 139.44]