Table 3.
Efficacy outcomes of full analysis set.
| Outcome | Butylphthalide Group (n = 62) | Placebo Group (n = 31) | Measure of effect | Unadjusted value (95% CI) | Adjusted value (95% CI) |
|---|---|---|---|---|---|
| Primary efficacy outcomes | |||||
| Phase difference of affected side at 14 days/ discharge—median (IQR), degree | 28.2 (18.4–44.7) | 25.6 (11.5–34.8) | Beta coefficient | 4.892 (−2.440 to 12.225) | 4.740 (−2.291 to 11.772) a |
| Phase difference of affected side at 90 days—degree—median (IQR), degree | 31.6 (18.7–41.8) | 21.5 (9.0–33.3) | Beta coefficient | 8.306 (0.138 to 16.474) | 8.802 (0.859 to 16.745)a |
| Secondary efficacy outcomes | |||||
| Phase difference of unaffected side at 14 days/discharge—median (IQR), degree | 37.1 (21.5–53.6) | 28.5 (18.8–36.0) | Beta coefficient | 9.574 (1.482 to 17.665) | 8.660 (0.945 to 16.376)a |
| Phase difference of unaffected side at 90 days—degree—median (IQR), degree | 35.8 (24.0–51.5) | 32.5 (19.8–43.1) | Beta coefficient | 6.748 (−2.068 to 15.564) | 5.517 (−3.030 to 14.063)a |
| Gain of affected side at 14 days/discharge— median (IQR) | 1.03 (0.76–1.34) | 1.11 (0.90–1.40) | Beta coefficient | −0.076 (−0.283 to 0.131) | −0.045 (−0.262 to 0.172) b |
| Gain of affected side at 90 days—median (IQR) | 0.98 (0.69–1.38) | 0.90 (0.74-1.38) | Beta coefficient | 0.013 (−0.209 to 0.236) | 0.069 (−0.145 to 0.283)b |
| Gain of unaffected side at 14 days/dis charge—median (IQR) | 1.18 (0.92–1.39) | 1.16 (0.88–1.58) | Beta coefficient | −0.029 (−0.295 to 0.237) | 0.012 (−0.223 to 0.248)b |
| Gain of unaffected side at 90 days—median (IQR) | 1.05 (0.74–1.39) | 1.10 (0.89–1.37) | Beta coefficient | −0.031 (−0.255 to 0.192) | −0.010 (−0.220 to 0.199)b |
| Stroke recurrence within 90 days—n (%) | 0 | 0 | Odds ratio | NA | NA |
| Death within 90 days—n (%) | 0 | 0 | Odds ratio | NA | NA |
| Functional independence at 14 days/dis charge—n (%) | 29.2 (47.1) | 9.6 (31.0) | Odds ratio | 1.986 (0.794 to 4.968) | 1.425 (0.446 to 4.554) c |
| Functional independence at 90 days—n (%) | 45.8 (73.9) | 19.2 (61.9) | Odds ratio | 1.737 (0.685 to 4.406) | 1.350 (0.478 to 3.810)c |
| NIHSS scores at 14 days/discharge—median (IQR) | 5 (2–8) | 5 (3–9) | Beta coefficient | −0.749 (−2.391 to 0.893) | 0.391 (−0.731 to 1.513)c |
| NIHSS scores at 90 days—median (IQR) | 2 (0–4) | 3 (1–5) | Beta coefficient | −0.749 (−2.017 to 0.519) | −0.003 (−1.028 to 1.022)c |
| Barthel scores at 14 days/discharge— median (IQR) | 58 (40–95) | 55 (25–80) | Beta coefficient | 6.539 (−6.537 to 19.616) | −1.590 (−9.677 to 6.497) d |
| Barthel scores at 90 days—median (IQR) | 94 (65–100) | 90 (75–100) | Beta coefficient | 0.363 (−8.784 to 9.511) | −3.307 (−11.164 to 4.551)d |
NA denotes not applicable. IQR: interquartile range; NIHSS: National Institutes of Health Stroke Scale.
aAdjusted for age, sex, and baseline phase difference.
bAdjusted for age, sex, and baseline Gain.
cAdjusted for age, sex, and baseline NIHSS score.
dAdjusted for age, sex, and baseline Barthel score.