Table 1.
Patient baseline characteristics
| Nanocurcumin (n = 27) | Placebo (n = 27) | p-value | |
|---|---|---|---|
| Sex | |||
| Male | 21 (78) | 18 (67) | 0.544 |
| Female | 6 (22) | 9 (33) | |
| Mean ± SD age (y) | 51.5 ± 13.1 | 58.5 ± 9.6 | 0.030 |
| Mean ± SD age of disease onset (y) | 49.2 ± 13.1 | 56.2 ± 9.5 | 0.028 |
| Mean ± SD BMI* | 25.4 ± 3.9 | 23.7 ± 4.5 | 0.237 |
| Onset | |||
| Bulbar | 6 (22) | 2 (7) | 0.250 |
| Spinal | 21 (78) | 25 (93) | |
| Bulbar symptoms | 18 (67) | 12 (44) | NA |
| Dysarthria | 11 | 11 | |
| Dysphagia | 14 | 9 | |
| Drooling | 10 | 8 | |
| Median (range) disease duration (months) | 24 (8–60) | 24 (5–84) | 0.599 |
| Mean ± SD ALSFRS-R | 36 ± 8.1 | 32.6 ± 8.2 | 0.134 |
| Progression rate | |||
| Slow | 15 (56) | 12 (44) | 0.128 |
| Intermediate | 11 (41) | 9 (33) | |
| Fast | 1 (4) | 6 (22) | |
| Median (range) ALSQ40 | 72 (16–256) | 67 (9–142) | 0.993 |
| Mean ± SD MMT | 108.2 ± 13 | 98.85 ± 15 | 0.019 |
| Mean ± SD FVC† | 86.8 ± 19.5 | 71 ± 30.2 | 0.118 |
Data are n (%) unless otherwise indicated
BMI = body mass index; ALSFRS-R = Revised Amyotrophic Lateral Sclerosis (ALS) Function Rating Scale; ALSQ40 = ALS Assessment Questionnaire-40; MMT = manual muscle testing; FVC = forced vital capacity
*BMI value available for 18 patients in the nanocurcumin group and 16 patients in the placebo group
†FVC available from 14 patients in the nanocurcumin group and 13 patients in the placebo group