Table 2.
Changes in the individual outcome measures from baseline to end of treatment in the ITT population treated with actovegin or placebo
| Actovegin | Placebo | Difference (95% CI) | P | |
|---|---|---|---|---|
| n | 281 | 286 | ||
| TSS | −5.5 ± 2.6 | −4.7 ± 2.9 | −0.86 (−1.22 to −0.50) | <0.0001 |
| Lancinating pain | −1.2 ± 1.2 | −1.0 ± 1.2 | −0.20 (−0.32 to −0.08) | 0.0015 |
| Burning pain | −1.5 ± 1.1 | −1.3 ± 1.2 | −0.26 (−0.38 to −0.14) | <0.0001 |
| Paresthesia | −1.3 ± 1.1 | −1.2 ± 1.1 | −0.21 (−0.33 to −0.09) | 0.0007 |
| Numbness | −1.4 ± 1.1 | −1.2 ± 1.1 | −0.24 (−0.38 to −0.10) | 0.0010 |
| VPT (volts) | −3.6 ± 4.5 | −2.9 ± 4.7 | −5% (−9 to −1) | 0.017 |
| NIS-LL | −3.9 ± 4.7 | −3.7 ± 5.0 | −0.48 (−1.01 to 0.06) | 0.080 |
| NIS-LL sensory function | −2.1 ± 2.1 | −1.7 ± 2.1 | −0.38 (−0.64 to −0.12) | 0.0045 |
| NIS-LL reflexes | −0.5 ± 1.3 | −0.6 ± 1.3 | −0.05 (−0.22 to 0.12) | 0.571 |
| NIS-LL muscle strength | −1.3 ± 3.1 | −1.4 ± 3.3 | −0.06 (−0.38 to 0.26 | 0.731 |
| SF-36, physical health | 4.4 ± 7.0 | 3.6 ± 7.1 | 0.91 (−0.18 to 2.00) | 0.101 |
| SF-36, mental health | 5.5 ± 10.6 | 3.8 ± 10.1 | 1.53 (0.17 to 2.88) | 0.027 |
Data are means ± SD, unless otherwise indicated. The first two columns represent the raw within-group differences over time. The last two columns represent model-adjusted between-group differences in the development over time.