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Table 3 Sleep parameters at the beginning and end of the trial

From: The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded placebo-controlled trial study

Variable

Group with sleep disorders

Group without sleep disorders

Baseline

After Intervention

Baseline

After Intervention

Subjective Sleep Quality

Melatonin

Very good

0 (0%)

12 (35.3%)

11 (32.4%)

12 (35.3%)

Fairly good

7 (20.6%)

16 (47.1%)

23 (67.6%)

22 (64.7%)

Fairly bad

17 (50%)

6 (17.6%)

0 (0%)

0 (0%)

Very bad

10 (29.4%)

0 (0%)

0 (0%)

0 (0%)

Placebo

Very good

0 (0%)

0 (0%)

6 (17.6%)

7 (20.6%)

Fairly good

10 (29.4%)

14 (41.2%)

28 (82.4%)

27 (79.4%)

Fairly bad

14 (41.2%)

10 (29.4%)

0 (0%)

0 (0%)

Very bad

10 (29.4%)

10 (29.4%)

0 (0%)

0 (0%)

P-Value

0.635

 < 0.001*

0.165

0.180

Sleep Latency

Melatonin

 < 15 min

0 (0%)

12 (35.3%)

13 (38.2%)

15 (44.1%)

16 – 30 min

8 (23.5%)

17 (50%)

17 (50%)

18 (52.9%)

31 – 60 min

8 (23.5%)

3 (8.8%)

3 (8.8%)

1 (2.9%)

 > 60 min

18 (52.9%)

2 (5.9%)

1 (2.9%)

0 (0%)

Placebo

 < 15 min

0 (0%)

0 (0%)

19 (55.9%)

20 (58.8%)

16 – 30 min

13 (38.2%)

13 (38.2%)

10 (29.4%)

13 (38.2%)

31 – 60 min

5 (14.7%)

5 (14.7%)

5 (14.7%)

1 (2.9%)

 > 60 min

16 (47.1%)

16 (47.1%)

0 (0%)

0 (0%)

P-Value

0.377

 < 0.001*

0.270

0.249

Sleep Duration

Melatonin

 > 7 h

1 (2.9%)

15 (44.1%)

32 (94.1%)

33 (97.1%)

6 – 7 h

12 (35.3%)

17 (50%)

1 (2.9%)

0 (0%)

5 – 6 h

14 (41.2%)

2 (5.9%)

1 (2.9%)

1 (2.9%)

 < 5 h

7 (20.6)

0 (0%)

0 (0%)

0 (0%)

Placebo

 > 7 h

0 (0%)

0 (0%)

33 (97.1%)

33 (97.1%)

6 – 7 h

16 (47.1%)

16 (47.1%)

0 (0%)

0 (0%)

5 – 6 h

11 (32.4%)

11 (32.4%)

1 (2.9%)

1 (2.9%)

 < 5 h

7 (20.6)

7 (20.6)

0 (0%)

0 (0%)

P-Value

0.669

 < 0.001*

0.569

1.000

Sleep Efficiency

Melatonin

 > 85%

10 (29.4%)

26 (76.5%)

33 (97.1%)

33 (97.1%)

75 – 84%

11 (32.4%)

5 (14.7%)

1 (2.9%)

1 (2.9%)

65 – 74%

10 (29.4%)

3 (8.8%)

0 (0%)

0 (0%)

 < 65%

3 (8.8%)

0 (0%)

0 (0%)

0 (0%)

Placebo

 > 85%

9 (26.5%)

9 (26.5%)

34 (100%)

34 (100%)

75 – 84%

10 (29.4%)

10 (29.4%)

0 (0%)

0 (0%)

65 – 74%

13 (38.2%)

13 (38.2%)

0 (0%)

0 (0%)

 < 65%

2 (5.9%)

2 (5.9%)

0 (0%)

0 (0%)

P-Value

0.748

 < 0.001*

0.317

0.317

Sleep Disturbance

Melatonin

Normal

1 (2.9%)

5 (14.7%)

30 (88.2%)

30 (88.2%)

Mild

30 (88.2%)

28 (82.4%)

4 (11.8%)

4 (11.8%)

Moderate

3 (8.8%)

1 (2.9%)

0 (0%)

0 (0%)

Severe

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Placebo

Normal

3 (8.8%)

3 (8.8%)

32 (94.1%)

32 (94.1%)

Mild

28 (82.4%)

28 (82.4%)

2 (5.9%)

2 (5.9%)

Moderate

3 (8.8%)

3 (8.8%)

0 (0%)

0 (0%)

Severe

0 (0%)

0 (0%)

0 (0%)

0 (0%)

P-Value

0.537

0.251

0.396

0.396

Use of Sleep Medication

Melatonin

Not during past month

34 (0%)

34 (0%)

34 (100%)

34 (100%)

Less than once a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Once or twice a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Three or more times a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Placebo

Not during past month

34 (100%)

34 (100%)

34 (100%)

34 (100%)

Less than once a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Once or twice a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Three or more times a week

0 (0%)

0 (0%)

0 (0%)

0 (0%)

P-Value

1.000

1.000

1.000

1.000

Daytime Dysfunction

Melatonin

Normal

0 (0%)

6 (17.6%)

12 (35.3%)

14 (41.2%)

Slight Dysfunction

13 (38.2%)

21 (61.8%)

22 (64.7%)

20 (58.8%)

Moderate Dysfunction

17 (50%)

6 (17.6%)

0 (0%)

0 (0%)

Severe Dysfunction

4 (11.8%)

1 (2.9%)

0 (0%)

0 (0%)

Placebo

Normal

0 (0%)

0 (0%)

17 (50%)

18 (52.9%)

Slight Dysfunction

11 (32.4%)

13 (38.2%)

16 (47.1%)

16 (47.1%)

Moderate Dysfunction

18 (52.9%)

16 (47.1%)

1 (2.9%)

0 (0%)

Severe Dysfunction

5 (14.7%)

5 (14.7%)

0 (0%)

0 (0%)

P-Value

0.583

 < 0.001*

0.294

0.335