Skip to main content

Table 3 Secondary efficacy outcome measures (ITT population: N = 87)

From: A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children

  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%)