Table 1.
Demographic and clinical characteristics of the study population at the time of treatment phase. Data are shown as means ± SD or as absolute value (n); P values refer to the statistical significance of the between‐group differences (t test for continuous variables, chi‐squared test for discrete variables)
| Placebo (n = 14) | TUDCA (n = 15) | P value | |
|---|---|---|---|
| Age (years) | 58.2 ± 12.9 | 54.0 ± 12.2 | 0.377 |
| Disease duration (years) | 1.0 ± 0.4 | 1.1 ± 0.7 | 0.814 |
| Gender | |||
| Men (n) | 9 | 10 | 0.893 |
| Women (n) | 5 | 5 | |
| ALSFRS‐R scale | 38.4 ± 6.4 | 38.7 ± 4.9 | 0.887 |
| ΔFS | 1.04 ± 0.6 | 1.45 ± 0.8 | 0.605 |
| FVC (%) | 96.1 ± 7.9 | 94.9 ± 12.2 | 0.735 |
| SF‐36 questionnaire | |||
| PCS | 38.0 ± 7.0 | 39.3 ± 9.9 | 0.695 |
| MCS | 45.4 ± 13.0 | 50.9 ± 11.8 | 0.263 |
| MRC scale | |||
| Right muscle group | 56.9 ± 7.6 | 58.2 ± 3.9 | 0.626 |
| Left muscle group | 54.9 ± 9.0 | 55.6 ± 8.9 | 0.851 |
TUDCA, tauroursodeoxycholic acid; ALSFRS‐R, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised; ΔFS, progression rate calculated as per 16; FVC, forced vital capacity; SF‐36, short form 36; PCS, physical component summary; MCS, mental component summary; MRC, Medical Research Council.