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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.