| 1.1 Spasticity: number of participants reporting reduction of 30% in the spasticity NRS (follow up 6‐14 weeks) |
5 |
1143 |
Odds Ratio (M‐H, Random, 95% CI) |
2.51 [1.56, 4.04] |
| 1.2 Spasticity: NRS as continuous outcome (follow up 2‐14 weeks) |
7 |
1262 |
Mean Difference (IV, Random, 95% CI) |
‐0.55 [‐0.94, ‐0.17] |
| 1.3 Pain: number of participants reporting pain relief of 50% or greater in the NRS‐PI (follow up 3 weeks) |
1 |
48 |
Odds Ratio (M‐H, Fixed, 95% CI) |
4.23 [1.11, 16.17] |
| 1.4 Pain: NRS‐PI as continuous outcome (follow up 3‐16 weeks) |
8 |
1451 |
Mean Difference (IV, Random, 95% CI) |
‐0.54 [‐0.91, ‐0.18] |
| 1.5 Withdrawn due to adverse events (follow up 3‐48 weeks) |
19 |
3110 |
Odds Ratio (M‐H, Random, 95% CI) |
2.41 [1.51, 3.84] |
| 1.6 PGIC: number of participants reporting much or very much improvement in the PGIC (follow up 4‐48 weeks) |
8 |
1215 |
Odds Ratio (M‐H, Random, 95% CI) |
1.80 [1.37, 2.36] |
| 1.7 Health related quality of life: change score from baseline (follow up 3‐48 weeks) |
8 |
1942 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.08 [‐0.17, 0.02] |
| 1.8 Health related quality of life: change score from baseline for each domain of SF‐36 (follow up 12‐14 weeks) |
4 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 1.8.1 Physical functioning |
4 |
|
Mean Difference (IV, Random, 95% CI) |
‐0.13 [‐2.05, 1.80] |
| 1.8.2 Role physical |
3 |
|
Mean Difference (IV, Random, 95% CI) |
‐0.28 [‐3.18, 2.63] |
| 1.8.3 Bodily pain |
3 |
|
Mean Difference (IV, Random, 95% CI) |
4.24 [0.07, 8.40] |
| 1.8.4 General health |
3 |
|
Mean Difference (IV, Random, 95% CI) |
‐0.12 [‐2.53, 2.29] |
| 1.8.5 Vitality |
3 |
|
Mean Difference (IV, Random, 95% CI) |
1.38 [‐2.85, 5.62] |
| 1.8.6 Social functioning |
3 |
|
Mean Difference (IV, Random, 95% CI) |
‐1.39 [‐6.78, 4.01] |
| 1.8.7 Role emotion |
3 |
|
Mean Difference (IV, Random, 95% CI) |
‐2.09 [‐5.50, 1.32] |
| 1.8.8 Mental health |
4 |
|
Mean Difference (IV, Random, 95% CI) |
0.41 [‐1.69, 2.50] |
| 1.9 SAEs: number of participants with SAEs (follow up 3‐48 weeks) |
20 |
3124 |
Odds Ratio (M‐H, Random, 95% CI) |
1.38 [0.96, 1.99] |
| 1.10 Specific AEs: number of participants reporting nervous system disorders (follow up 4‐48 weeks) |
7 |
1154 |
Odds Ratio (M‐H, Random, 95% CI) |
2.61 [1.53, 4.44] |
| 1.11 Specific AEs: number of participants reporting psychiatric disorders (follow up 4‐48 weeks) |
6 |
1122 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.94 [1.31, 2.88] |
| 1.12 Specific AEs: number of participants reporting drug tolerance (follow up 14‐48 weeks) |
2 |
458 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.07 [0.12, 75.95] |
| 1.13 Spasticity: Ashworth or Modified Ashworth (follow up 2‐50 weeks) |
11 |
1777 |
Mean Difference (IV, Random, 95% CI) |
‐0.23 [‐0.44, ‐0.03] |
| 1.14 Fatigue as continuous outcome (follow up 4‐14 weeks) |
5 |
928 |
Std. Mean Difference (IV, Random, 95% CI) |
0.04 [‐0.26, 0.34] |
| 1.15 Sleep quality: NRS as continuous outcome (follow up 4‐14 weeks) |
7 |
1205 |
Mean Difference (IV, Random, 95% CI) |
‐0.66 [‐1.10, ‐0.22] |
| 1.16 Sleep quality: number of participants reporting an improvement in the NRS sleep (follow up 6‐14 weeks) |
2 |
756 |
Odds Ratio (M‐H, Random, 95% CI) |
1.79 [1.30, 2.46] |
| 1.17 Depression: Beck Depression Inventory as continuous outcome |
3 |
495 |
Mean Difference (IV, Random, 95% CI) |
0.17 [‐0.90, 1.24] |
| 1.18 Activities of daily living: Barthel index as continuous outcome |
4 |
1134 |
Mean Difference (IV, Random, 95% CI) |
‐0.08 [‐0.32, 0.16] |
| 1.19 Number of caregivers reporting improvement on the CGIC (follow up 4‐48 weeks) |
4 |
582 |
Odds Ratio (M‐H, Random, 95% CI) |
1.66 [1.15, 2.41] |
