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Table 7 Pittsburgh Sleep Quality Index (PSQI) measures, Clinical Global Impression of Improvement (CGI-I) and World Health Organization-5 Index in the 65-80 age group.

From: Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

   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
N MAX PRM 136 164   
  Placebo 144 62   
PSQI PRM -1.86 (2.93) -3.34 (3.37) -0.64 (-1.25, -0.02) -0.70 (-1.17, -0.23)
Global score Placebo -1.19 (2.53) -2.08 (2.92) P = 0.042 P = 0.003
PSQI PRM -0.32 (0.71) -0.59 (0.82) -0.09 (-0.23, 0.05) -0.15 (-0.25, -0.04)
Component 1 Placebo -0.19 (0.65) -0.34 (0.85) P = 0.217 P = 0.006
PSQI PRM -0.43 (0.87) -0.75 (0.99) -0.23 (-0.41, -0.04) -0.24 (-0.38, -0.10)
Component 2 Placebo -0.22 (0.74) -0.52 (0.95) P = 0.018 P = 0.001
PSQI PRM -0.48 (0.89) -0.86 (1.08) -0.10 (-0.29, 0.10) -0.10 (-0.25, 0.05)
Component 3 Placebo -0.40 (0.89) -0.65 (0.96) P = 0.328 P = 0.177
PSQI PRM -0.32 (0.96) -0.79 (1.22) -0.05 (-0.27, 0.17) -0.10 (-0.26, 0.06)
Component 4 Placebo -0.29 (1.04) -0.47 (1.05) P = 0.638 P = 0.236
PSQI PRM 0.01 (0.41) -0.04 (0.43) -0.05 (-0.13, 0.02) 0.00 (-0.05, 0.05)
Component 5 Placebo 0.03 (0.39) -0.02 (0.42) P = 0.162 P = 0.973
PSQI PRM -0.01 (0.12) 0.01 (0.18)
Component 6 Placebo 0.00 (0.00) 0.00 (0.00)   
PSQI PRM -0.30 (0.95) -0.31 (0.94) -0.04 (-0.19, 0.11) -0.07 (-0.17, 0.02)
Component 7 Placebo -0.12 (0.69) -0.10 (0.86) P = 0.636 P = 0.137
PSQI PRM -25.4 (50.9) -32.7 (49.3) -13.7 (-23.5, -3.9) -12.1 (-19.1, -5.1)
Question 2 Placebo -8.9 (48.0) -19.0 (65.8) P = 0.006 P = 0.001
PSQI PRM 0.58 (1.03) 1.05 (1.29) 0.10 (-0.13, 0.33) 0.14 (-0.04, 0.32)
Question 4 Placebo 0.48 (1.00) 0.71 (1.08) P = 0.381 P = 0.120
  PRM 3.34 (1.17) 2.70 (1.17) -0.12 (-0.37, 0.14) -0.20 (-0.38, -0.02)
CGI-I Placebo 3.54 (0.85) 3.19 (1.11) P = 0.364 P = 0.027
WHO-5 PRM 1.02 (3.73) 1.51 (4.05) 0.42 (-0.34, 1.18), 0.55 (-0.02, 1.13)
Index Placebo 0.27 (3.15) 0.35 (4.21) P = 0.281 P = 0.058
  1. 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)
  2. *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).
  3. Regression models for PSQI Component 6 not fitted due to lack of variability in the data.
  4. Data shown are for values recorded at each visit, and regression models do not include baseline adjustment, since CGI-I at baseline not defined.