Skip to main content

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.
Back to article page

BMC Medicine

ISSN: 1741-7015

Contact us