Table 2
Changes in outcome measures from the second baseline measurements at five and 14 weeks of treatment and three weeks after end of treatment, according to treatment group
| Week 5 of treatment | Week 14 of treatment | Three weeks after end of treatment | |||||||
|---|---|---|---|---|---|---|---|---|---|
| PSM (n = 31) | Placebo (n = 31) | Δ (95% CI) p value | PSM (n = 31) | Placebo (n = 31) | Δ (95% CI) p value | PSM (n = 31) | Placebo (n = 31) | Δ (95% CI) p value | |
| Change is calculated as the scores at or after intervention minus the scores at baseline and is presented as mean (SD). The difference in change between groups (Δ) is calculated from the change in the pyridostigmine group minus the change in the placebo group and is presented as mean difference (95% confidence interval) and the p value of the t test. | |||||||||
| *n = 9; †n = 12; ‡n = 19; §n = 20; ¶n = 23; **n = 26; ††n = 28; ‡‡n = 29; §§n = 30. | |||||||||
| CI, confidence interval; FSS, fatigue severity scale; Max, maximum; MF, median frequency; NHPE, Nottingham health profile, category “energy”; NMT, neuromuscular transmission; PSM, pyridostigmine. | |||||||||
| NHPE (range 0–100) | −10.8 (35.9) | −10.8 (26.4) | 0.0 (16.0 to −16.0) | −18.3 (36.4) | −17.2 (33.2) | −1.1 (−18.8 to 16.6) | −6.5 (37.9) | −8.6 (25.8) | 2.2 (−14.3 to 18.6) |
| p = 0.11 | p = 0.03 | 1.00 | p = 0.01 | p = 0.01 | 0.90 | p = 0.35 | p = 0.07 | 0.80 | |
| FSS (range 1–7) | −0.2 (0.7) | −0.4 (0.5) | 0.1 (−0.2 to 0.4) | −0.6 (0.9) | −0.4 (0.9) | −0.2 (−0.6 to 0.3) | −0.5 (1.0) | −0.4 (0.6) | −0.1 (−0.6 to 0.3) |
| p = 0.07 | p<0.01 | 0.44 | p<0.01 | p = 0.01 | 0.48 | p<0.01 | p<0.01 | 0.48 | |
| Subjective benefit of treatment | |||||||||
| Question 1 | 0.5 (0.7) | 0.5 (0.8) | −0.1 (−0.5 to 0.3) | 0.5 (0.9) | 0.5 (0.9) | −0.1 (−0.5 to 0.4) | |||
| p<0.01 | p<0.001 | 0.61 | p = 0.01 | p<0.01 | 0.78 | ||||
| Question 2 | 0.4 (0.8) | 0.4 (0.9) | −0.1 (−0.5 to 0.4) | 0.5 (0.9) | 0.5 (0.9) | −0.1 (−0.5 to 0.4) | |||
| p = 0.01 | p = 0.02 | 0.76 | p = 0.01 | p<0.01 | 0.78 | ||||
| Two minute walking distance (m) | 8.6 (9.9)§§ | 5.8 (5.9) | 2.8 (−1.4 to 7.0) | 10.2 (9.4) | 3.0 (8.8) | 7.2 (2.6 to 11.9) | 12.7 (9.3) | 6.0 (9.6) | 6.8 (2.0 to 11.6) |
| p<0.001 | p<0.001 | 0.18 | p<0.001 | p = 0.07 | 0.003 | p<0.001 | p<0.01 | 0.01 | |
| Max walking performance, 75 m (s) | −1.1 (3.5) | 0.5 (5.8)§§ | −1.5 (−4.0 to 0.9) | −1.6 (4.4) | 0.1 (4.0)†† | −1.7 (−3.9 to 0.5) | −1.9 (4.1)‡‡ | 0.6 (4.4)§§ | −2.6 (−4.8 to −0.3) |
| p = 0.09 | p = 0.76 | 0.21 | p = 0.06 | p = 0.89 | 0.13 | p = 0.02 | p = 0.62 | 0.03 | |
| Duration of walking (% of total time) | 1.5 (1.3)† | 1.0 (1.7) * | 0.5 (−0.8 to 1.9) | ||||||
| p<0.01 | p = 0.12 | 0.42 | |||||||
| Quadriceps strength (Nm) | 6.7 (13.7) | 5.0 (13.9) | 1.7 (−5.3 to 8.7) | 12.7 (21.4) | 6.0 (13.4) | 6.7 (−2.4 to 15.7) | 5.1 (19.0) | 3.7 (12.1) | 1.5 (−6.6 to 9.5) |
| p = 0.01 | p = 0.06 | 0.63 | p<0.01 | p = 0.02 | 0.15 | p = 0.14 | p = 0.10 | 0.72 | |
| Max voluntary activation (range 0–100) | 6.5 (14.3)¶ | −4.7 (11.3)‡ | 11.1 (3.0 to 19.3) | 7.7 (14.2)¶ | 1.1 (14.2)‡ | 6.6 (−2.2 to 15.5) | 5.8 (13.2)** | −3.3 (12.7)§ | 9.1 (1.3 to 16.8) |
| p = 0.04 | p = 0.09 | 0.01 | p = 0.02 | p = 0.74 | 0.14 | p = 0.03 | p = 0.26 | 0.02 | |
| Muscle fatiguability (MF0–5s–MF25–30s) | 0.1 (2.9) ** | −0.0 (3.5)†† | 0.2 (−1.6 to 1.9) | 0.9 (3.4)** | 0.2 (3.3)** | 0.7 (−1.1 to 2.6) | 0.9 (3.1)** | 0.4 (4.0)†† | 0.4 (−1.5 to 2.4) |
| p = 0.82 | p = 0.96 | 0.85 | p = 0.18 | p = 0.80 | 0.43 | p = 0.17 | p = 0.58 | 0.66 | |
| NMT, jitter (μs) | −5.6 (16.0) | −2.8 (21.1)†† | −2.8 (−12.5 to 6.9) | ||||||
| p = 0.06 | p = 0.49 | 0.57 | |||||||
