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Table 5 Analysis of IBS-QOL Responsiveness

From: Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients

  Treatment group n Mean change from baseline Mean difference from placebo t-Value Degrees of freedom p-Value Effect sizes
d Pooled d Placebo
IBS-QOL total score, Observed Data(a) 5 mg 66 19.73 2.02 0.64 189 0.522 0.09 0.09
25 mg 135 18.75 1.04 0.43 258 0.664 0.05 0.05
100 mg 130 25.25 7.54 3.10 253 0.002 0.39 0.33
200 mg 107 25.06 7.35 2.68 230 0.008 0.35 0.32
Placebo 125 17.70       
IBS-QOL total score, Longitudinal Model(b) 5 mg 105 19.33 2.00 1.09 262 0.279 0.13 0.09
25 mg 167 18.46 1.13 0.67 324 0.507 0.07 0.05
100 mg 163 24.53 7.20 4.20 320 <.001 0.47 0.31
200 mg 160 23.33 6.00 3.64 317 <.001 0.41 0.26
Placebo 159 17.33       
  1. Note: (a) Effect size estimates based on observed standard deviations (sPooled, sPlacebo) (b) Effect size estimates based on estimated standard deviations from a mixed-effects model for IBS-QOL total score with fixed effects of treatment, time, treatment by time interaction, and Baseline IBS-QOL total score and random effects for intercept and time σ ^ Pooled , σ ^ Placebo .