Table 3.
Effects of 3 weeks treatment with prolonged release melatonin (PRM) and placebo on sleep diary-recorded sleep latency in the low excretors and the elderly patients.
| Treatment | Treatment effect difference PRM - placebo; (95% confidence interval) |
P value* effect PRM versus placebo |
||
|---|---|---|---|---|
| PRM | Placebo | |||
| Low excretor population | ||||
| N | 86 | 86 | ||
| Baseline: mean (SD) | 74.1 (54.9) | 75.5 (58.5) | ||
| Treatment: mean (SD) | 65.1 (59.9) | 66.5 (51.6) | ||
| Change from baseline: mean (SD) | -9.0 (50.5) | -9.0 (48.7) | -0.6 (-14.0, 12.7) | 0.924 |
| 65-80 year population | ||||
| N | 137 | 144 | ||
| Baseline: mean (SD) | 76.7 (63.7) | 72.5 (51.4) | ||
| Treatment: mean (SD) | 57.6 (51.8) | 70.9 (54.0) | ||
| Change from baseline: mean (SD) | -19.1 (47.3) | -1.7 (47.8) | -15.6 (-25.3, -6.0), | 0.002 |
*Linear regression model with terms for treatment (PRM versus placebo), baseline sleep latency and age group (≥65 or <65 - only for the low excretors).
PRM, prolonged release melatonin; SD, standard deviation.