Table 5.
Selected outcomes at 6 months.
|
Overall, n = 40 median [IQR] |
rhGH n = 20 median [IQR] |
Placebo n = 20 median [IQR] |
p-value | |
|---|---|---|---|---|
| Disability Rating Scale (DRS) | 1.5 [0.0, 4.0] | 2.0 [0.0, 4.5] | 1.0 [0.0, 3.5] | 0.59 |
| Galveston Orientation Assessment Test (GOAT) | 99.5 [90.0, 100] | 98.5 [92.5, 100] | 99.5 [89.0, 100] | 1.0 |
| Digit span age standardized score | 9.0 [6.0, 13.0] | 9.0 [6.5, 12.0] | 9.0 [6.0, 13.0] | 0.84 |
| Processing speed index age standardized score | 84.0 [73.0, 99.0] | 82.5 [73.0, 96.0] | 88.0 [79.0, 99.0] | 0.80 |
| Digit symbol age standardized score | 7.0 [5.0, 9.0] | 6.0 [4.0, 9.0] | 7.0 [6.0, 9.0] | 0.31 |
| Symbol search age standardized score | 8.0 [6.0, 11.0] | 7.0 [5.0, 11.0] | 8.0 [7.0, 11.0] | 0.44 |
| California Verbal Learning Test (CVLT) T score | 41.5 [32.0, 55.0] | 38.0 [32.0, 59.0] | 42.0 [32.0, 55.0] | 0.81 |
| Trails A T score | 42.0 [34.0, 51.0] | 39.5 [19.5, 53.5] | 43.0 [40.0, 50.0] | 0.34 |
| Trails B T score | 47.0 [33.0, 56.0] | 47.0 [29.5, 53.5] | 47.0 [35.0, 56.0] | 0.46 |
| Controlled Oral Word Association Test (COWA) T score | 34.0 [26.0, 44.0] | 31.0 [24.5, 45.5] | 36.0 [33.0. 42.0] | 0.26 |
| Brief Symptom Inventory (BSI)—Average T score | 51.2 [43.9, 59.2] | 51.6 [46.9, 59.6] | 48.8 [43.9, 58.6] | 0.89 |
| Functional Independence Measure (FIM) Motor | 110.0 (17.9) | 112.2 (12.9) | 107.8 (22.0) | 0.82 |
| FIM cognitive | 31.5 (5.3) | 31.9 (3.7) | 31.2 (6.7) | 0.89 |
| FIM total | 141.5 (21.9) | 144.1 (14.3) | 139.0 (27.6) | 0.99 |
| FIM motor change from baseline | 71.3 (22.3) | 80.1 (18.9) | 63.5 (22.6) | 0.02 |
| FIM cognitive change from baseline | 22.3 (7.1) | 24.7 (6.0) | 20.1 (7.4) | 0.02 |
| FIM total change from baseline | 93.6 (26.6) | 104.8 (20.8) | 83.6 (27.7) | 0.02 |
| Patient Health Questionnaire (PHQ-9) | 9.8 (19.6) | 6.5 (7.5) | 13.2 (26.7) | 0.85 |
| Fatigue severity scale | 26.5 (14.9) | 23.6 (13.0) | 29.5 (16.6) | 0.27 |
| Rivermead post-concussion symptoms questionnaire | 14.4 (13.9) | 15.2 (15.0) | 13.6 (13.0) | 0.78 |
| Satisfaction with life scale | 21.2 (9.5) | 22.2 (10.2) | 20.3 (9.0) | 0.56 |
| Short Form health survey (SF 36)—physical health | 266.6 (57.8) | 274.6 (50.1) | 258.3.7 (65.4) | 0.74 |
| Short Form health survey (SF 36)—mental health | 246.2 (55.4) | 260.3 (55.4) | 231.3 (52.8) | 0.10 |
| 6 month Glascow Outcome Score-Extended (GOSE) score | 0.72 | |||
| 3—Severe disability | 6 | 3 | 3 | |
| 4 | 6 | 5 | 1 | |
| 5—Moderate disability | 4 | 2 | 2 | |
| 6 | 5 | 1 | 4 | |
| 7—Good recovery | 11 | 4 | 7 | |
| 8 | 8 | 5 | 3 |
2-sided p-value (α = 0.05) from PROC NPAR1WAY Wilcoxon Rank sum test. Bold values highlight those that meet the pre-specified nominal threshold for statistical significance (p < 0.05).