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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.

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
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
  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.
  5. CI, confidence interval.