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Table 4 PSQI total and component scores throughout the study (mean ± sd) (ES: effect sizes)

From: Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study

 

baseline

week 6

week 12

week 18

week 24

P

Total scores

16.0 ± 3.2

12.4 ± 4.0***

11.0 ± 4.6***

11.2 ± 4.4***

11.1 ± 5.1***

<0.0001

ES

 

1.19

1.56

1.50

1.53

 

Sleep quality

2.54 ± 0.5

1.67 ± 0.8***

1.46 ± 0.8***

1.44 ± 0.8***

1.53 ± 0.9***

<0.0001

ES

 

1.74

2.16

2.20

2.02

 

Sleep latency

2.51 ± 0.7

2.10 ± 0.9

1.80 ± 1.1***

2.08 ± 1.0*

1.87 ± 1.0***

<0.0001

ES

 

0.59

0.99

0.61

0.89

 

Sleep duration

2.56 ± 0.6

1.90 ± 1.0***

1.56 ± 1.1***

1.51 ± 1.2***

1.54 ± 1.2***

<0.0001

ES

 

1.10

1.66

1.75

1.72

 

Sleep efficiency

2.62 ± 0.7

1.92 ± 1.2***

1.72 ± 1.3***

1.69 ± 1.2***

1.62 ± 1.2***

<0.0001

ES

 

1.00

1.27

1.33

1.41

 

Sleep disturbance

2.33 ± 0.5

1.97 ± 0.6

1.85 ± 0.6**

1.97 ± 0.7

1.44 ± 1.0***

<0.0001

ES

 

0.72

0.90

0.72

1.68

 

Sleep medications

1.41 ± 1.4

0.82 ± 1.3

0.51 ± 1.1**

0.62 ± 1.2*

0.72 ± 1.2*

= 0.0028

ES

 

0.42

0.62

0.56

0.48

 

Daytime dysfunction

2.28 ± 0.6

2.00 ± 0.9

1.95 ± 0.9

1.92 ± 0.9

1.92 ± 1.0

= 0.0454

ES

 

0.47

0.51

0.55

0.55

 
  1. *: p < 0.05, **: p < 0.01, and ***: p < 0.001 in relation to baseline (Tukey's post-test). Bold: large effect sizes.