Table 2.
Efficacy outcomes of per-protocol population.
| Outcome | Butylphthalide Group (n = 52) | Placebo Group (n = 28) | 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 | 28.4 (18.6–45.2) | 22.0 (10.9–34.2) | Beta coefficient | 7.663 (0.509 to 14.818) | 6.799 (0.014 to 13.584) b |
| Phase difference of affected side at 90 days—degreea—median (IQR), degree | 31.9 (21.0–43.1) | 21.3 (8.6–32.4) | Beta coefficient | 11.995 (3.255 to 20.736) | 12.219 (3.647 to 20.791)b |
| Secondary efficacy outcomes | |||||
| Phase difference of unaffected side at 14 days/discharge—median (IQR), degree | 37.9 (21.2–54.3) | 26.8 (17.9–35.8) | Beta coefficient | 11.011 (2.640 to 19.382) | 9.905 (1.897 to 17.913)b |
| Phase difference of unaffected side at 90 days—degreea—median (IQR), degree | 35.8 (27.9–51.6) | 32.3 (18.5–42.9) | Beta coefficient | 9.177 (0.090 to 18.263) | 8.079 (−0.872 to 17.030)b |
| Gain of affected side at 14 days/discharge— median (IQR) | 1.02 (0.77–1.33) | 1.06 (0.90–1.38) | Beta coefficient | −0.062 (−0.254 to 0.130) | −0.021 (−0.218 to 0.177) c |
| Gain of affected side at 90 days—median (IQR)a | 0.98 (0.68–1.35) | 0.91 (0.73–1.41) | Beta coefficient | −0.027 (−0.268 to 0.215) | 0.018 (−0.227 to 0.263)c |
| Gain of unaffected side at 14 days/dis charge—median (IQR) | 1.18 (0.93–1.38) | 1.14 (0.88–1.58) | Beta coefficient | −0.014 (−0.271 to 0.244) | 0.052 (−0.182 to 0.287)c |
| Gain of unaffected side at 90 days—median (IQR)a | 1.12 (0.73–1.40) | 1.11 (0.86–1.50) | Beta coefficient | −0.044 (−0.291 to 0.202) | −0.029 (−0.269 to 0.210)c |
| 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/discharge—n (%) | 24 (46.2) | 9 (32.1) | Odds ratio | 1.810 (0.691 to 4.737) | 1.317 (0.351 to 4.942) d |
| Functional independence at 90 days—n (%)a | 33 (73.3) | 19 (73.1) | Odds ratio | 1.013 (0.341 to 3.013) | 0.630 (0.176 to 2.260)d |
| NIHSS scores at 14 days/discharge—median (IQR) | 5 (2–8) | 5 (3–9) | Beta coefficient | −0.755 (−2.537 to 1.026) | 0.458 (−0.772 to 1.689)d |
| NIHSS scores at 90 daysa—median (IQR) | 2 (0–4) | 2 (1–4) | Beta coefficient | −0.412 (−1.760 to 0.936) | 0.346 (−0.786 to 1.477)d |
| Barthel scores at 14 days/discharge— median (IQR) | 68 (36–95) | 60 (26–88) | Beta coefficient | 5.426 (−8.973 to 19.824) | −3.320 (−12.255 to 5.614) e |
| Barthel scores at 90 daysa—median (IQR) | 95 (68–100) | 95 (75–100) | Beta coefficient | −0.504 (−10.754 to 9.745) | −3.702 (−12.741 to 5.338)e |
NA denotes not applicable. IQR: interquartile range; NIHSS: National Institutes of Health Stroke Scale.
aData on outcomes at 90 days were available for 71 patients (butylphthalide group, n = 45; placebo group, n = 26).
bAdjusted for age, sex, and baseline phase difference.
cAdjusted for age, sex, and baseline Gain.
dAdjusted for age, sex, and baseline NIHSS score.
eAdjusted for age, sex, and baseline Barthel score.