Table 1.
Demographic and baseline characteristics.
| Placebo (N = 59) | OLE (N = 59) | Total (N = 118) | p values | ||
|---|---|---|---|---|---|
| Gender | n/n miss | 59/0 | 59/0 | 118/0 | 0.71 |
| Male, n (%) | 29 (49.1%) | 31 (52.5%) | 60 (50.8%) | ||
| Female, n (%) | 30 (50.9%) | 28 (47.5%) | 58 (49.1%) | ||
| Ethnicity | n/n miss | 59/0 | 59/0 | 118/0 | 0.19 |
| Asian, n (%) | 1 (1.7%) | 0 (0%) | 1 (0.8%) | ||
| African, n (%) | 2 (3.4%) | 1 (1.7%) | 3 (2.5%) | ||
| Caucasian, n (%) | 56 (94.9%) | 58 (98.3%) | 114 (96.6%) | ||
| Age (years) | n/n miss | 59/0 | 59/0 | 118/0 | 0.23 |
| Mean (SEM) | 64.3 (0.89) | 62.8 (0.85) | 63.6 (0.61) | ||
| Median | 64 | 62 | 63 | ||
| Q1, Q3 | 59, 69 | 57, 67 | 57, 68 | ||
| Min, Max | 55, 82 | 53, 79 | 53, 82 | ||
| BMI (kg/m2) | n/n miss | 59/0 | 59/0 | 118/0 | 0.55 |
| Mean (SEM) | 25.6 (0.46) | 25.3 (0.32) | 25.4 (0.28) | ||
| Median | 25.5 | 25.2 | 25.4 | ||
| Q1, Q3 | 23.5, 28.5 | 23.9, 27.1 | 23.7, 27.7 | ||
| Min, Max | 18.5, 35.2 | 19.2, 29.9 | 18.5, 35.2 | ||
| Overall KOOS | n/n miss | 56/3 | 59/0 | 115/3 | 0.22 |
| Mean (SEM) | 54.1 (2.5) | 49.8 (2.0) | 51.9 (1.6) | ||
| Median | 52.8 | 51.3 | 52.3 | ||
| Q1, Q3 | 41.9, 70.2 | 39.7, 60.6 | 40.6, 65.0 | ||
| Min, Max | 11.8, 87.8 | 15.2, 87.6 | 11.8, 87.8 | ||
| Coll2-1 NO2 (pg/mL) | n/n miss | 57/2 | 59/0 | 116/2 | 0.35 |
| Mean (SEM) | 2694 (181) | 2638 (249) | 2666 (154) | ||
| Median | 2309 | 2068 | 2136 | ||
| Q1, Q3 | 1686, 3421 | 1517, 2963 | 1614, 3345 | ||
| Min, Max | 932, 6466 | 253, 10304 | 253, 10304 | ||
| KOOS pain | n/n miss | 59/0 | 59/0 | 118/0 | 0.025 |
| Mean (SEM) | 61.0 (2.5) | 52.2 (2.4) | 56.6 (1.8) | ||
| Median | 58.3 | 52.8 | 58.3 | ||
| Q1, Q3 | 47.2, 75.0 | 38.9, 66.7 | 41.7, 69.4 | ||
| Min, Max | 16.7, 94.4 | 0.0, 86.1 | 0.0, 94.4 | ||
| KOOS Adl | n/n miss | 59/0 | 59/0 | 118/0 | 0.44 |
| Mean (SEM) | 63.0 (2.9) | 60.1 (2.5) | 61.6 (1.9) | ||
| Median | 63.2 | 63.2 | 63.2 | ||
| Q1, Q3 | 44.1, 82.4 | 44.1, 76.5 | 44.1, 76.5 | ||
| Min, Max | 7.4, 98.5 | 14.7, 97.1 | 7.4, 98.5 | ||
| KOOS symptom | n/n miss | 59/0 | 59/0 | 118/0 | 0.5 |
| Mean (SEM) | 65.9 (2.5) | 63.6 (2.2) | 64.7 (1.7) | ||
| Median | 64.3 | 67.9 | 67.9 | ||
| Q1, Q3 | 50.0, 82.1 | 50.0, 78.6 | 50.0, 78.6 | ||
| Min, Max | 28.6, 100.0 | 28.6, 89.3 | 28.6, 100.0 | ||
| KOOS sport | n/n miss | 56/3 | 59/0 | 115/3 | 0.27 |
| Mean (SEM) | 36.4 (3.4) | 30.5 (2.6) | 33.4 (2.1) | ||
| Median | 30 | 30 | 30 | ||
| Q1, Q3 | 12.5, 60.0 | 15.0, 40.0 | 15.0, 50.0 | ||
| Min, Max | 0.0, 90.0 | 0.0, 95.0 | 0.0, 95.0 | ||
| KOOS Qol | n/n miss | 59/0 | 59/0 | 118/0 | 0.88 |
| Mean (SEM) | 43.8 (2.9) | 42.6 (2.2) | 43.2 (1.8) | ||
| Median | 37.5 | 43.8 | 43.8 | ||
| Q1, Q3 | 31.3, 62.5 | 31.3, 50.0 | 31.3, 56.3 | ||
| Min, Max | 0.0, 87.5 | 6.3, 75.0 | 0.0, 87.5 | ||
| Knee pain VAS score at rest | n/n miss | 59/0 | 59/0 | 118/0 | 0.76 |
| Mean (SEM) | 45.2 (2) | 45.4 (2.4) | 45.3 (1.5) | ||
| Median | 45 | 47 | 45 | ||
| Q1, Q3 | 40, 58 | 40, 60 | 40, 59 | ||
| Min, Max | 10, 73 | 0, 74 | 0, 74 | ||
| Knee pain VAS score at walking | n/n miss | 59/0 | 59/0 | 118/0 | 0.82 |
| Mean (SEM) | 58.1 (1.4) | 57.3 (1.4) | 57.7 (1) | ||
| Median | 59 | 59 | 59 | ||
| Q1, Q3 | 50, 65 | 48, 70 | 49, 66 | ||
| Min, Max | 40, 100 | 32, 75 | 32, 100 |
BMI, body mass index; KOOS, Knee injury and Osteoarthritis Outcome Score; OLE, olive leaf extract; SEM, standard error of the mean; VAS, Visual analog scale.