Table 2 IBS score and GI symptoms at the beginning and end of the trial
Variable | Group with sleep disorders | Group without sleep disorders | ||||
|---|---|---|---|---|---|---|
Baseline | After Intervention | Baseline | After Intervention | |||
IBS Score | Melatonin | Mild | 2 (5.8%) | 20 (58.8%) | 5 (14.7%) | 20 (58.8%) |
Moderate | 16 (47.1%) | 9 (26.5%) | 13 (38.2%) | 9 (26.5%) | ||
Severe | 16 (47.1%) | 5 (14.7%) | 16 (47.1%) | 5 (14.7%) | ||
Placebo | Mild | 5 (14.7%) | 10 (29.4%) | 2 (5.8%) | 8 (23.5%) | |
Moderate | 15 (44.1%) | 15 (44.1%) | 21 (61.8%) | 22 (64.7%) | ||
Severe | 14 (41.2%) | 9 (26.5%) | 11 (32.3%) | 4 (11.8%) | ||
P-Value | 0.424 | 0.022* | 0.536 | 0.025* | ||
Severity of Abdominal Pain | Melatonin | No Pain | 0 (0%) | 9 (26.5%) | 0 (0%) | 7 (20.6%) |
Not Very Severe | 15 (44.1%) | 18 (52.9%) | 8 (23.5%) | 16 (47.1%) | ||
Quite Severe | 8 (23.5%) | 5 (14.7%) | 22 (64.7%) | 10 (29.4%) | ||
Severe | 8 (23.5%) | 2 (5.9%) | 4 (11.8%) | 1 (2.9%) | ||
Very Severe | 3 (8.8%) | 0 (0%) | 0 (0%) | 0 (0%) | ||
Placebo | No Pain | 0 (0%) | 4 (11.8%) | 0 (0%) | 4 (11.8%) | |
Not Very Severe | 18 (52.9%) | 17 (50%) | 14 (41.2%) | 10 (29.4%) | ||
Quite Severe | 6 (17.6%) | 5 (14.7%) | 14 (41.2%) | 17 (50%) | ||
Severe | 7 (20.6%) | 6 (17.6%) | 6 (17.6%) | 3 (8.8%) | ||
Very Severe | 3 (8.8%) | 2 (5.9%) | 0 (0%) | 0 (0%) | ||
P-Value | 0.575 | 0.034* | 0.384 | 0.033* | ||
Frequency of Abdominal Pain in 10 days | Melatonin | Median | 5.5 | 3 | 5 | 3 |
Q1 | 4 | 0 | 4 | 2 | ||
Q3 | 9 | 6.25 | 7.25 | 4.5 | ||
Placebo | Median | 4 | 4 | 5 | 5 | |
Q1 | 4 | 3 | 3 | 3 | ||
Q3 | 9 | 8 | 7 | 6 | ||
P-Value | 0.623 | 0.019* | 0.170 | 0.010* | ||
Severity of Abdominal Bloating | Melatonin | No Bloating | 0 (0%) | 8 (23.5%) | 0 (0%) | 17 (50%) |
Not Very Severe | 16 (47.1%) | 19 (55.9%) | 8 (23.5%) | 12 (35.3%) | ||
Quite Severe | 9 (26.5%) | 4 (11.8%) | 22 (64.7%) | 5 (14.7%) | ||
Severe | 7 (20.6%) | 3 (8.8%) | 4 (11.8%) | 0 (0%) | ||
Very Severe | 2 (5.9%) | 0 (0%) | 0 (0%) | 0 (0%) | ||
Placebo | No Bloating | 0 (0%) | 2 (5.9%) | 1 (2.9%) | 7 (20.6%) | |
Not Very Severe | 19 (55.9%) | 17 (50%) | 14 (41.2%) | 14 (41.2%) | ||
Quite Severe | 10 (29.4%) | 11 (32.4%) | 16 (47.1%) | 11 (32.3%) | ||
Severe | 5 (14.7%) | 4 (11.8%) | 2 (5.9%) | 1 (2.9%) | ||
Very Severe | 0 (0%) | 0 (0%) | 1 (2.9%) | 1 (2.9%) | ||
P-Value | 0.292 | 0.018* | 0.261 | 0.005* | ||
Satisfaction with Bowel Habits | Melatonin | Very Happy | 0 (0%) | 10 (29.4%) | 0 (0%) | 5 (14.7%) |
Quite Happy | 5 (14.7%) | 14 (41.2%) | 6 (17.6%) | 13 (38.2%) | ||
Unhappy | 24 (70.6%) | 7 (20.6%) | 24 (70.6%) | 14 (41.2%) | ||
Very Unhappy | 5 (14.7%) | 3 (8.8%) | 4 (11.8%) | 2 (5.9%) | ||
Placebo | Very Happy | 0 (0%) | 2 (5.9%) | 0 (0%) | 0 (0%) | |
Quite Happy | 7 (20.6%) | 10 (29.4%) | 2 (5.9%) | 9 (26.5%) | ||
Unhappy | 23 (67.6%) | 19 (55.9%) | 29 (85.3%) | 22 (64.7%) | ||
Very Unhappy | 4 (11.8%) | 3 (8.8%) | 3 (8.8%) | 3 (8.8%) | ||
P-Value | 0.512 | 0.004* | 0.436 | 0.018* | ||
Disease's Impact on Patient's Life | Melatonin | Not at All | 0 (0%) | 9 (26.5%) | 0 (0%) | 4 (11.8%) |
Not Much | 3 (8.8%) | 11 (32.3%) | 2 (5.8%) | 18 (52.9%) | ||
Quite a Lot | 18 (52.9%) | 10 (29.4%) | 22 (64.7%) | 10 (29.4%) | ||
Completely | 13 (38.2%) | 4 (11.8%) | 10 (29.4%) | 2 (5.8%) | ||
Placebo | Not at All | 0 (0%) | 2 (5.8%) | 0 (0%) | 0 (0%) | |
Not Much | 2 (5.8%) | 7 (20.6%) | 5 (14.7%) | 10 (29.4%) | ||
Quite a Lot | 18 (52.9%) | 15 (44.1%) | 22 (64.7%) | 20 (58.8%) | ||
Completely | 14 (41.2%) | 10 (29.4%) | 7 (20.6%) | 4 (11.8%) | ||
P-Value | 0.720 | 0.004* | 0.222 | 0.003* | ||
Frequency of Defecations per Week | Melatonin | Median | 3.5 | 2 | 4 | 2 |
Q1 | 2 | 1 | 1 | 1 | ||
Q3 | 4 | 3 | 5 | 4 | ||
Placebo | Median | 2 | 2 | 3 | 2 | |
Q1 | 1 | 1 | 2 | 2 | ||
Q3 | 4 | 4 | 4 | 3.25 | ||
P-Value | 0.165 | 0.573 | 0.449 | 0.361 | ||
Stool Consistency | Melatonin | Normal | 5 (14.7%) | 19 (55.9%) | 0 (0%) | 21 (61.8%) |
Not Normal | 29 (85.3%) | 15 (44.1%) | 34 (100%) | 13 (38.2%) | ||
Placebo | Normal | 3 (8.8%) | 5 (14.7%) | 2 (5.8%) | 5 (14.7%) | |
Not Normal | 31 (91.2%) | 29 (85.3%) | 32 (94.1%) | 29 (85.3%) | ||
P-Value | 0.455 | < 0.001* | 0.154 | 0.029* | ||
Quality of Life Improvement | Melatonin | Yes | 23 (67.6%) | 21 (61.8%) | ||
No | 11 (32.4%) | 13 (38.2%) | ||||
Placebo | Yes | 9 (26.5%) | 12 (35.3%) | |||
No | 25 (73.5%) | 22 (64.7%) | ||||
P-Value | 0.001* | 0.030* | ||||