Table 4.
Change in exploratory endpoints day 0–day 56: mWOMAC and SF-36 (Least square [LS] means and 95% confidence interval [CI] of the LS means)
| Endpoint | Group | |||
|---|---|---|---|---|
| HD-hBO (N = 55) | MD-hBO (N = 53) | LD-hBO (N = 60) | Placebo (N = 55) | |
| mWOMAC pain change | ||||
| LS mean | − 7.9 | − 8.2 | − 8 | − 1.8 |
| LS mean 95% CI | (− 9.0, − 6.8) | (− 9.3, − 7.1) | (− 9.0, − 7.0) | (− 2.9, − 0.7) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| mWOMAC stiffness change | ||||
| LS mean | − 2.6 | − 2.6 | − 2.4 | − 0.8 |
| LS mean 95% CI | (− 3.1, − 2.0) | (− 3.2, − 2.1) | (− 2.9, − 1.9) | (− 1.3, − 0.2) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| mWOMAC function change | ||||
| LS mean | − 26 | − 27.8 | − 24.7 | − 5 |
| LS mean 95% CI | (− 30.1, − 21.9) | (− 31.9, − 23.6) | (− 28.6, − 20.8) | (− 9.0, − 0.9) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| mWOMAC total change | ||||
| LS mean | − 36.5 | − 38.6 | − 34.3 | − 7.5 |
| LS mean 95% CI | (− 42.0, − 30.9) | (− 44.3, − 33.0) | (− 39.6, − 29.0) | (− 13.0, − 2.0) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 Physical function change | ||||
| LS mean | 35.8 | 38.2 | 36.2 | 3.1 |
| LS mean 95% CI | (29.1, 42.5) | (31.3, 45.0) | (29.8, 42.6) | (− 3.6, 9.8) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 physical health change | ||||
| LS mean | 62.7 | 56.6 | 60.8 | 2.7 |
| LS mean 95% CI | (51.5, 74.0) | (45.2, 68.1) | (50.1, 71.6) | (− 8.5, 14.0) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 body pain change | ||||
| LS mean | 32 | 35.3 | 32.5 | 2.9 |
| LS mean 95% CI | (25.2, 38.8) | (28.4, 42.3) | (26.0, 39.1) | (− 3.9, 9.7) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 social function change | ||||
| LS mean | 27.3 | 31.1 | 25.2 | 1.6 |
| LS mean 95% CI | (20.9, 33.7) | (24.6, 37.6) | (19.1, 31.3) | (− 4.8, 8.1) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 mental function change | ||||
| LS mean | 18.3 | 21 | 18.1 | − 1.8 |
| LS mean 95% CI | (12.7, 23.9) | (15.3, 26.7) | (12.8, 23.5) | (− 7.4, 3.9) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 emotional health change | ||||
| LS mean | 45.5 | 43.4 | 42.8 | − 0.6 |
| LS mean 95% CI | (32.6, 58.3) | (30.3, 56.5) | (30.5, 55.1) | (− 13.5, 12.3) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 vitality change | ||||
| LS mean | 20.2 | 21.7 | 20.9 | − 0.5 |
| LS mean 95% CI | (14.2, 26.2) | (15.6, 27.8) | (15.2, 26.6) | (− 6.4, 5.5) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
| SF-36 general health change | ||||
| LS mean | 16.4 | 18.4 | 17.8 | 2.5 |
| LS mean 95% CI | (11.5, 21.3) | (13.4, 23.4) | (13.2, 22.5) | (− 2.4, 7.4) |
| Nominal p value | 0.0003 | < 0.0001 | < 0.0001 | |
| SF-36 total score change | ||||
| LS mean | 258.1 | 265.7 | 254.4 | 10.9 |
| LS mean 95% CI | (210.5, 305.6) | (217.2, 314.1) | (208.9, 299.9) | (− 36.6, 58.5) |
| Nominal p value | < 0.0001 | < 0.0001 | < 0.0001 | |
Pair wise comparisons (hBO group vs. placebo) utilized t tests without multiplicity correction and p values are presented as nominal