Tenderness values (kp/cm2) and area under the curve (AUC) over six hours (kp h/cm2) (intention to treat)
| Time (hours) | Escin 1% (n=54) | Escin 2% (n=51) | Placebo (n=51) | |
|---|---|---|---|---|
| 0 | Mean (median) | 2.1 (1.9) | 2.0 (1.9) | 2.0 (1.7) |
| SD | 1.12 | 1.00 | 0.93 | |
| Q1; Q3 | 1.4; 2.6 | 1.3; 2.7 | 1.4; 2.6 | |
| 1 | Mean (median) | 3.0 (2.8) | 3.0 (2.9) | 2.5 (2.2) |
| SD | 1.25 | 1.31 | 1.12 | |
| Q1; Q3 | 2.1; 3.7 | 2.0; 4.0 | 1.8; 3.0 | |
| n=53 | n=49 | n=49 | ||
| 2 | Mean (median) | 3.9 (3.9) | 3.7 (3.6) | 2.8 (2.5) |
| SD | 1.30 | 1.32 | 1.17 | |
| Q1; Q3 | 2.9; 4.7 | 2.8; 4.5 | 1.9; 3.1 | |
| n=53 | n=49 | |||
| 3 | Mean (median) | 4.2 (3.9) | 4.2 (4.0) | 3.0 (2.6) |
| SD | 1.38 | 1.55 | 1.24 | |
| Q1; Q3 | 3.2; 5.1 | 3.2; 5.1 | 2.0; 3.8 | |
| n=53 | n=50 | |||
| 4 | Mean (median) | 4.3 (4.0) | 4.3 (4.2) | 3.1 (2.9) |
| SD | 1.41 | 1.54 | 1.31 | |
| Q1; Q3 | 3.3; 5.5 | 3.4; 5.5 | 2.2; 3.8 | |
| n=53 | n=50 | |||
| 6 | Mean (median) | 4.4 (4.1) | 4.5 (4.5) | 3.3 (3.0) |
| SD | 1.50 | 1.53 | 1.30 | |
| Q1; Q3 | 3.2; 5.5 | 3.4; 5.5 | 2.4; 4.1 | |
| n=52 | n=50 | n=50 | ||
| 24 | Mean (median) | 4.4 (4.2) | 4.7 (4.7) | 3.6 (3.5) |
| SD | 1.40 | 1.55 | 1.31 | |
| Q1; Q3 | 3.4; 5.6 | 3.5; 5.7 | 2.8; 4.4 | |
| AUC over 6 h | Mean (median) | 22.9 (21.9) | 23.1 (22.8) | 17.2 (15.8) |
| SD | 7.64 | 8.15 | 6.91 | |
| Q1; Q3 | 18.1; 27.7 | 17.8; 29.0 | 12.1; 20.3 | |
| AUC over 24 h | Mean (median) | 102.6 (95.7) | 105.1 (105.0) | 79.0 (72.0) |
| SD | 33.39 | 35.76 | 30.02 | |
| Q1; Q3 | 77.5; 127.6 | 80.8; 128.5 | 58.7; 95.9 | |
| Confirmatory test results (a priori ordered hypotheses) for the AUC over 6 h | ||||
| Priority | Comparison | p Value | Mean treatment effect (kp h/cm2) | 95% confidence interval (kp h/cm2) |
| 1st | Escin 1% v placebo | 0.0001 | +5.70 | +2.88 to +8.52 |
| 2nd | Escin 2% v placebo | 0.0002 | +5.86 | +2.89 to +8.83 |
| 3rd | Escin 1% v 2% | 0.9186 | −0.16 | −3.22 to +2.90 |