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Chapter 7 174 Table S7.6 Stool frequency and stool consistency in patients with IBS subtype diarrhea. Measurement Placebo N =29 Small-intestinal release Peppermint oil N =25 Ileocolonic release Peppermint oil N =29 Estimated means (SE) Estimated means (SE) Treatment effect (95% CI) P -value Estimated means (SE) Treatment effect (95% CI) P -value Frequency scores in patients with IBS subtype diarrhea § Baseline 11.31 (1.20) 11.80 (1.29) - - 9.79 (1.20) - - Week 1 11.90 (1.17) 11.16 (1.26) -1.23 (-3.49; 1.03) 0.285 11.07 (1.17) 0.69 (-1.48; 2.86) 0.532 Week 2 9.46 (1.24) 10.96 (1.32) 1.01 (-2.12; 4.13) 0.525 8.65 (1.24) 0.71 (-2.32; 3.74) 0.644 Week 3 7.96 (1.05) 9.87 (1.15) 1.42 (-1.99; 4.82) 0.414 7.92 (1.05) 1.47 (-1.78; 4.73) 0.374 Week 4 8.01 (1.28) 9.91 (1.39) 1.41 (-2.67; 5.49) 0.498 8.46 (1.29) 1.97 (-1.95; 5.89) 0.323 Week 5 7.43 (1.06) 7.16 (1.17) -0.76 (-4.70; 3.18) 0.704 6.75 (1.11) 0.83 (-2.98; 4.65) 0.667 Week 6 6.46 (1.23) 6.67 (1.30) -0.28 (-4.63; 4.08) 0.901 7.05 (1.26) 2.11 (-2.15; 6.37) 0.330 Week 7 6.17 (0.86) 5.16 (0.96) -1.50 (-5.43; 2.43) 0.452 5.11 (0.91) 0.46 (-3.34; 4.26) 0.813 Week 8 4.53 (0.63) 4.62 (0.71) -0.40 (-4.13; 3.33) 0.832 4.72 (0.68) 1.71 (-1.89; 5.31) 0.350 Stool consistency in patients with IBS subtype diarrhea ± Baseline 4.64 (0.19) 4.81 (0.21) - - 5.10 (0.19) - - Week 1 4.47 (0.19) 4.78 (0.21) 0.14 (-0.28; 0.56) 0.518 5.24 (0.19) 0.31 (-0.10; 0.72) 0.141 Week 2 4.49 (0.20) 4.87 (0.21) 0.20 (-0.26; 0.67) 0.385 5.10 (0.20) 0.15 (-0.30; 0.60) 0.521 Week 3 4.25 (0.20) 4.98 (0.22) 0.56 (0.06; 1.06) 0.028 5.26 (0.20) 0.55 (0.07; 1.02) 0.023 Week 4 4.27 (0.20) 4.87 (0.22) 0.42 (-0.11; 0.95) 0.118 5.28 (0.20) 0.54 (0.04; 1.05) 0.036 Week 5 4.75 (0.20) 5.19 (0.22) 0.26 (-0.27; 0.80) 0.333 5.39 (0.20) 0.18 (-0.34; 0.70) 0.496 Week 6 4.51 (0.20) 5.37 (0.21) 0.69 (0.14; 1.24) 0.014 5.40 (0.20) 0.43 (-0.11; 0.97) 0.119 Week 7 4.54 (0.20) 5.05 (0.23) 0.34 (-0.24; 0.92) 0.255 5.62 (0.21) 0.62 (0.06; 1.18) 0.030 Week 8 4.62 (0.21) 5.07 (0.23) 0.28 (-0.33; 0.89) 0.366 5.44 (0.22) 0.36 (-0.23; 0.95) 0.232 Treatment effect is the corrected difference in change from baseline between small-intestinal release peppermint oil and placebo, or ileocolonic release peppermint oil and placebo, obtained from linear mixed modelling. P -value is level of significance of comparison between small-intestinal release peppermint oil, or ileocolonic release peppermint oil and placebo. The treatment period consisted of eight weeks (week 1 to week 8). § Frequency scores: Defined as Spontaneous Bowel Movements per week; ± Stool consistency: Weekly average score assessed using the Bristol Stool Form Scale. Scale: 1=separate hard lumps, like nuts (difficult to pass); 2=sausage- shaped, but lumpy; 3=like a sausage but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5= soft blobs with clear-cut edges (passed easily); 6=fluffy pieces with ragged edges, a mushy stool; 7=watery, no solid pieces, entirely liquid.

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