Table 4.
Assessment of Multidimensional Fatigue Inventory scores (MFI)
| Evaluation | Mean ± SD | P value (vs. baseline) | P value (vs. placebo) | 95% CI (vs. Baseline) | 95% CI (vs. Placebo) | P value, change from baseline (vs. placebo) | |
|---|---|---|---|---|---|---|---|
| General Fatigue | |||||||
| Placebo | Baseline | 10.54 ± 2.12 | - | - | - | - | |
| Day 42 | 10.68 ± 1.61 | 0.4063 | - | -0.55, 0.83 | - | - | |
| Day 84 | 10.58 ± 1.53 | 0.9458 | - | -0.63, 0.71 | - | - | |
| LN18178 | Baseline | 11.23 ± 2.41 | 0.1058 | -0.14, 1.52 | - | ||
| Day 42 | 11.02 ± 1.47 | 0.3739 | 0.5976 | -0.53, 0.95 | -0.22, 0.92 | 0.4170 | |
| Day 84 | 9.58 ± 2.44 | 0.0020 | 0.054 | 0.75, 2.55 | 0.25, 1.75 | 0.0336 | |
| Physical fatigue | |||||||
| Placebo | Baseline | 9.03 ± 1.36 | - | - | - | - | |
| Day 42 | 8.63 ± 1.27 | 0.0050 | - | -0.08, 0.88 | - | - | |
| Day 84 | 8.22 ± 1.39 | 0.0001 | - | 0.31, 1.31 | - | - | |
| LN18178 | Baseline | 8.86 ± 1.59 | 0.5267 | -0.37, 0.71 | - | ||
| Day 42 | 8.4 ± 1.12 | 0.0254 | 0.6051 | -0.05, 0.97 | -0.21, 0.67 | 0.8792 | |
| Day 84 | 6.47 ± 1.4 | <0.000 | <0.0001 | 1.83, 2.95 | 1.24, 2.26 | <0.0001 | |
| Reduced activity | |||||||
| Placebo | Baseline | 8.36 ± 1.44 | - | - | - | - | |
| Day 42 | 8.25 ± 1.21 | 0.6517 | - | -0.38, 0.60 | - | - | |
| Day 84 | 8.85 ± 1.49 | 0.1022 | - | -0.04, 1.02 | - | - | |
| LN18178 | Baseline | 8.53 ± 1.38 | 0.5157 | -0.35, 0.69 | - | ||
| Day 42 | 8.58 ± 1.13 | 0.8266 | 0.1663 | -0.42, 0.52 | -0.10, 0.76 | 0.5777 | |
| Day 84 | 7.98 ± 2.56 | 0.1061 | 0.1022 | -0.21, 1.31 | 0.10, 1.64 | 0.0954 | |
| Reduced motivation | |||||||
| Placebo | Baseline | 11.36 ± 1.84 | - | - | - | ||
| Day 42 | 11.25 ± 1.43 | 0.7078 | - | -0.49, 0.71 | - | - | |
| Day 84 | 11.86 ± 2.07 | 0.0773 | - | -0.21, 1.21 | - | - | |
| LN18178 | Baseline | 11.7 ± 2.1 | 0.3460 | -0.39, 1.07 | - | ||
| Day 42 | 11.11 ± 1.29 | 0.0410 | 0.3568 | -0.06, 1.24 | -0.36, 0.64 | 0.0783 | |
| Day 84 | 11.16 ± 3.95 | 0.3367 | 0.4424 | -0.63, 1.71 | -0.45, 1.85 | 0.3295 | |
| Mental fatigue | |||||||
| Placebo | Baseline | 11.36 ± 1.7 | - | - | - | - | |
| Day 42 | 11.32 ± 1.31 | 0.8442 | - | -0.51, 0.59 | - | - | |
| Day 84 | 10.56 ± 1.57 | 0.0039 | - | 0.20, 1.40 | - | - | |
| LN18178 | Baseline | 11.65 ± 2.07 | 0.4049 | -0.41, 0.99 | - | ||
| Day 42 | 10.53 ± 1.38 | < 0.0001 | < 0.0001 | 0.47, 1.77 | 0.30, 1.28 | 0.0005 | |
| Day 84 | 8.67 ± 1.52 | < 0.0001 | < 0.0001 | 2.31, 3.65 | 1.32, 2.46 | < 0.0001 | |
| Total score | |||||||
| Placebo | Baseline | 56.51 ± 6.17 | - | - | - | - | |
| Day 42 | 56.1 ± 3.74 | 0.4831 | - | -1.45, 2.27 | - | - | |
| Day 84 | 55.61 ± 5.12 | 0.4962 | - | -1.17, 2.97 | - | - | |
| LN18178 | Baseline | 58.07 ± 8.07 | 0.2430 | -1.08, 4.20 | - | ||
| Day 42 | 55.11 ± 3.94 | 0.0091 | 0.0100 | 0.60, 5.32 | -0.42, 2.40 | 0.0877 | |
| Day 84 | 50.09 ± 12.58 | 0.0009 | 0.3767 | 4.06, 11.90 | 2.01, 9.03 | 0.1866 | |
Values present mean ± SD. placebo (n=59) and LN18178 (n=57). CI: Confidence interval; P < 0.05 was considered as statistically significant for 'within the group' and 'between the groups' comparison analysis using paired t-test and ANCOVA, respectively, as described in materials and methods.