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 5 Change in irritable bowel syndrome-related quality of life and level of anxiety and depression (Hospital Anxiety and Depression Score)
TreatmentBaselineWeek 12Change from baselineWithin-group comparisonComparison with placeboComparison with low- and high-dose
nmean ± SDnmean ± SDmean ± SDP valueP valueP value
IBS-QoL
Placebo12166.4 ± 17.511873.2 ± 19.07.0 ± 12.3< 0.001NA0.412
Low-dose12463.9 ± 19.011071.6 ± 19.37.4 ± 12.3< 0.0010.812NA
High-dose12268.2 ± 16.511376.5 ± 15.88.5 ± 8.8< 0.0010.238NA
HADS total score
Placebo1199.2 ± 5.61108.6 ± 6.6-0.4 ± 4.30.302NA0.134
Low-dose12210.1 ± 5.71099.2 ± 6.0-1.0 ± 4.40.0340.435NA
High-dose1189.7 ± 5.51098.2 ± 5.8-1.5 ± 3.9< 0.0010.071NA
HADS-Anxiety
Placebo1215.9 ± 3.51145.3 ± 3.6-0.4 ± 2.60.036NA0.246
Low-dose1226.1 ± 3.31095.5 ± 3.1-0.6 ± 2.70.0110.726NA
High-dose1196.2 ± 3.31095.0 ± 3.1-1.0 ± 2.2< 0.0010.099NA
HADS-Depression
Placebo1193.4 ± 2.91113.4 ± 3.60.0 ± 2.30.906NA0.162
Low-dose1244.0 ± 3.01093.7 ± 3.4-0.3 ± 2.20.2580.376NA
High-dose1193.5 ± 2.91103.2 ± 3.1-0.4 ± 2.40.0410.125NA