Table 3 Secondary efficacy outcome measures (ITT population: N = 87)
Lactulose | PEG 4000 | Relative risk | p | |
|---|---|---|---|---|
(N = 44) | (N = 43) | [95% CI] | ||
Stool consistency | ||||
Mean symptom score ± SD | 1.27 [1.1 - 1.46] | 0.0012 | ||
Baseline | 1.16 ± 0.83 | 1.35 ± 0.95 | ||
Week 2 | 1.71 ± 0.88 | 2.19 ± 0.73 | ||
Week 4 | 1.71 ± 0.80 | 2.09 ± 0.65 | ||
Change (W4 – baseline) | 0.87 | |||
Worsened | 6 (13.6%) | 6 (14.0%) | ||
No change | 11 (25.0%) | 13 (30.2%) | ||
Improved | 27 (61.4%) | 24 (55.8%) | ||
Ease of stool passage | ||||
Mean symptom score ± SD | 1.35 [1.13 - 1.62] | 0.001 | ||
Baseline | 0.93 ± 0.95 | 0.98 ± 0.77 | ||
Week 2 | 1.23 ± 0.86 | 1.66 ± 0.75 | ||
Week 4 | 1.18 ± 0.72 | 1.61 ± 0.79 | ||
Change (W4 – baseline) | 0.83 | |||
Worsened | 6 (13.6%) | 4 (9.3%) | ||
No change | 21 (47.7%) | 20 (46.5%) | ||
Improved | 17 (38.6%) | 19 (44.2%) | ||
Cramps | ||||
Mean symptom score ± SD | 0.65 [0.31 - 1.35] | 0.25 | ||
Baseline | 0.71 ± 0.85 | 0.32 ± 0.64 | ||
Week 2 | 0.36 ± 0.72 | 0.23 ± 0.36 | ||
Week 4 | 0.43 ± 0.79 | 0.14 ± 0.35 | ||
Change (W4 – baseline) | 0.02 | |||
Decreased | 17 (38.6%) | 7 (16.3%) | ||
No change | 21 (47.7%) | 33 (76.7%) | ||
Increased | 6 (13.6%) | 3 (7.0%) | ||
Flatulence | ||||
Mean symptom score ± SD | 0.87 [0.62 - 1.22] | 0.42 | ||
Baseline | 0.86 ± 0.80 | 0.63 ± 0.73 | ||
Week 2 | 0.64 ± 0.75 | 0.70 ± 0.74 | ||
Week 4 | 0.96 ± 0.91 | 0.61 ± 0.66 | ||
Change (W4 – baseline) | 1.00 | |||
Decreased | 10 (22.7%) | 11 (25.6%) | ||
No change | 23 (52.3%) | 22 (51.2%) | ||
Increased | 11 (25.0%) | 10 (23.3%) | ||
Anal irritation | ||||
Mean symptom score ± SD | 0.33 [0.11 - 1.02] | 0.055 | ||
Baseline | 0.80 ± 1.11 | 0.54 ± 0.96 | ||
Week 2 | 0.18 ± 0.54 | 0.09 ± 0.37 | ||
Week 4 | 0.27 ± 0.73 | 0.02 ± 0.15 | ||
Change (W4 – baseline) | 0.45 | |||
Decreased | 15 (34.1%) | 12 (27.9%) | ||
No change | 26 (59.1%) | 30 (69.8%) | ||
Increased | 3 (6.8%) | 1 (2.3%) |