Table 5.
Pittsburgh Sleep Quality Index (PSQI) measures, Clinical Global Impression of Improvement (CGI-I) and World Health Organization-5 Index in the low excretors.
| Change from baseline Mean (SD) |
Treatment effects | ||||
|---|---|---|---|---|---|
| Short term | Long term * | ||||
| Visit 3 | Visit 7 |
Estimate (95% CI) P-value |
Estimate (95% CI) P-value |
||
| NMAX | PRM | 86 | 101 | ||
| Placebo | 86 | 31 | |||
| PSQI | PRM | -2.13 (2.89) | -3.78 (3.65) | -0.40 (-1.19, 0.38) | -0.66 (-1.30, -0.01) |
| Global score | Placebo | -1.62 (2.59) | -2.94 (2.91) | P = 0.313 | P = 0.046 |
| PSQI | PRM | -0.30 (0.83) | -0.72 (0.80) | -0.02 (-0.22, 0.19) | -0.13 (-0.29, 0.02) |
| Component 1 | Placebo | -0.26 (0.67) | -0.42 (1.06) | P = 0.884 | P = 0.086 |
| PSQI | PRM | -0.37 (0.72) | -0.90 (1.02) | -0.12 (-0.33, 0.10) | -0.17 (-0.36, 0.02) |
| Component 2 | Placebo | -0.26 (0.71) | -0.68 (0.79) | P = 0.278 | P = 0.080 |
| PSQI | PRM | -0.50 (0.89) | -0.87 (1.04) | -0.04 (-0.29, 0.21) | -0.13 (-0.33, 0.06) |
| Component 3 | Placebo | -0.44 (0.83) | -0.65 (0.88) | P = 0.735 | P = 0.169 |
| PSQI | PRM | -0.40 (1.09) | -0.89 (1.25) | 0.09 (-0.20, 0.39) | -0.01 (-0.24, 0.21) |
| Component 4 | Placebo | -0.45 (0.99) | -0.77 (1.12) | P = 0.537 | P = 0.918 |
| PSQI | PRM | -0.09 (0.33) | -0.01 (0.48) | -0.10 (-0.18, -0.03) | -0.01 (-0.06, 0.05) |
| Component 5 | Placebo | 0.03 (0.32) | -0.03 (0.31) | P = 0.008 | P = 0.811 |
| PSQI | PRM | 0.00 (0.00) | 0.00 (0.00) | † | † |
| Component 6 | Placebo | 0.00 (0.00) | 0.00 (0.00) | ||
| PSQI | PRM | -0.47 (0.82) | -0.39 (0.99) | -0.17 (-0.35, 0.01) | -0.06 (-0.17, 0.05) |
| Component 7 | Placebo | -0.24 (0.87) | -0.39 (0.84) | P = 0.067 | P = 0.283 |
| PSQI | PRM | -18.3 (52.4) | -41.3 (59.0) | -0.2 (-13.2, 12.8) | -11.6 (-22.0, -1.1) |
| Question 2 | Placebo | -18.5 (51.7) | -33.1 (92.2) | P = 0.980 | P = 0.030 |
| PSQI | PRM | 0.63 (1.10) | 1.11 (1.33) | 0.09 (-0.20, 0.38) | 0.17 (-0.07, 0.41) |
| Question 4 | Placebo | 0.51 (0.94) | 0.81 (1.08) | P = 0.539 | P = 0.164 |
| CGI-I‡ | PRM | 3.22 (1.05) | 2.50 (1.19) | -0.15 (-0.46, 0.16) | -0.25 (-0.49, -0.01) |
| Placebo | 3.31 (0.98) | 3.06 (1.21) | P = 0.339 | P = 0.042 | |
| WHO-5 | PRM | 1.27 (3.53) | 1.79 (4.27) | 1.21 (0.22, 2.20), | 0.91 (0.16, 1.66) |
| Index | Placebo | -0.03 (3.45) | 1.06 (3.56) | P = 0.016 | P = 0.017 |
Mean (standard deviation; SD) changes from baseline at Visits 3 and 7, with estimates of short-term treatment effect (linear regression model, adjusted for baseline value and age) and long-term treatment effect (mixed effects regression model, adjusted for baseline value, age and visit; global treatment effect reported).
*Global treatment effect is estimated using a mixed-effect model for repeated measures and takes into account the treatment effect difference over the 26-weeks (at Visits 3, 4, 5, 6 and 7).
†Regression models for PSQI Component 6 not fitted due to lack of variability in the data.
‡Data shown are for values recorded at each visit, and regression models do not include baseline adjustment, since CGI-I at baseline not defined.
CI, confidence interval.