Clinical Trials Study
Copyright ©The Author(s) 2016.
World J Gastroenterol. Dec 28, 2016; 22(48): 10631-10642
Published online Dec 28, 2016. doi: 10.3748/wjg.v22.i48.10631
Table 3 Irritable bowel syndrome symptom severity score item scores at baseline and end of intervention
TreatmentBaselineWeek 12Change from baselineWithin-group comparisonComparison with placeboComparison with low- and high-dose
nmean ± SDnmean ± SDmean ± SDP valueP valueP value
Severity of pain
Placebo12120.2 ± 20.611818.5 ± 20.7-2.2 ± 21.80.024NA0.303
Low-dose12424.1 ± 22.311018.3 ± 18.6-5.2 ± 24.40.0050.640NA
High-dose12224.3 ± 21.511316.4 ± 17.8-7.9 ± 21.8< 0.0010.189NA
Number of days with pain over 10 d
Placebo1143.8 ± 2.81112.8 ± 2.8-1.0 ± 2.7< 0.001NA0.234
Low-dose1154.4 ± 2.81053.3 ± 2.6-1.1 ± 2.9< 0.0010.470NA
High-dose1214.1 ± 2.81062.9 ± 2.4-1.2 ± 2.5< 0.0010.634NA
Bloating/Distension
Placebo12139.0 ± 28.011830.7 ± 25.6-8.3 ± 23.6< 0.001NA0.669
Low-dose12240.5 ± 29.911031.0 ± 25.7-9.4 ± 29.6< 0.0010.905NA
High-dose12237.1 ± 26.611331.0 ± 27.3-6.1 ± 25.80.0020.535NA
Satisfaction with bowel habits
Placebo12157.4 ± 22.611847.3 ± 24.2-10.3 ± 21.4< 0.001NA0.964
Low-dose12459.4 ± 22.711046.3 ± 19.8-11.8 ± 22.4< 0.0010.701NA
High-dose12255.0 ± 19.711346.4 ± 22.6-8.3 ± 23.3< 0.0010.757NA
Interference of IBS with quality of life
Placebo12162.4 ± 17.011848.6 ± 22.1-13.9 ± 20.3< 0.001NA0.210
Low-dose12460.8 ± 16.911050.1 ± 19.4-9.8 ± 16.5< 0.0010.133NA
High-dose12259.8 ± 13.511347.9 ± 16.5-11.7 ± 13.6< 0.0010.509NA