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Efficacy and safety of peppermint oil in IBS 175 7 Table S7.7 Stool frequency and stool consistency in patients with IBS subtype constipation. Measurement Placebo N =14 Small-intestinal release Peppermint oil N =12 Ileocolonic release Peppermint oil N =16 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 constipation § Baseline 6.79 (0.82) 5.96 (0.88) - - 5.56 (0.76) - - Week 1 7.14 (0.83) 6.58 (0.90) 0.27 (-1.79; 2.32) 0.796 5.56 (0.78) -0.36 (-2.27; 1.56) 0.711 Week 2 5.86 (0.70) 5.42 (0.76) 0.39 (-2.05; 2.82) 0.753 3.81 (0.65) -0.82 (-3.08; 1.44) 0.473 Week 3 5.57 (0.72) 4.80 (0.80) 0.05 (-2.71; 2.82) 0.969 4.57 (0.70) 0.22 (-2.36; 2.81) 0.864 Week 4 5.86 (0.79) 3.67 (0.82) -1.36 (-4.36; 1.64) 0.370 4.58 (0.74) -0.05 (-2.88; 2.77) 0.972 Week 5 6.18 (1.01) 4.47 (1.10) -0.88 (-4.49; 2.73) 0.630 4.59 (0.96) -0.37 (-3.74; 3.00) 0.830 Week 6 5.19 (0.80) 3.90 (0.86) -0.46 (-3.68; 2.76) 0.778 4.24 (0.76) 0.27 (-2.73; 3.28) 0.857 Week 7 5.86 (0.89) 3.72 (0.96) -1.31 (-4.77; 2.16) 0.454 4.12 (0.89) -0.52 (-3.80; 2.77) 0.755 Week 8 3.81 (0.78) 4.15 (0.83) 1.17 (-2.09; 4.42) 0.478 3.69 (0.78) 1.10 (-1.99; 4.19) 0.479 Stool consistency in patients with IBS subtype constipation ± Baseline 3.23 (0.32) 2.99 (0.34) - - 3.08 (0.30) - - Week 1 3.07 (0.32) 3.47 (0.34) 0.64 (-0.35; 1.63) 0.202 3.57 (0.30) 0.65 (-0.27; 1.57) 0.167 Week 2 2.82 (0.32) 2.87 (0.34) 0.29 (-0.74; 1.31) 0.579 3.53 (0.30) 0.85 (-0.10; 1.80) 0.080 Week 3 3.73 (0.32) 3.43 (0.35) -0.07 (-1.13; 1.00) 0.903 3.66 (0.31) 0.07 (-0.93; 1.07) 0.895 Week 4 3.35 (0.33) 3.15 (0.34) 0.04 (-1.06; 1.14) 0.945 3.68 (0.31) 0.48 (-0.57; 1.52) 0.372 Week 5 3.01 (0.33) 2.88 (0.35) 0.10 (-1.02; 1.23) 0.855 3.54 (0.31) 0.68 (-0.38; 1.74) 0.207 Week 6 3.10 (0.33) 3.42 (0.35) 0.56 (-0.59; 1.71) 0.337 3.55 (0.31) 0.59 (0.49; 1.67) 0.279 Week 7 3.17 (0.33) 3.81 (0.35) 0.87 (-0.30; 2.05) 0.142 3.92 (0.33) 0.90 (-0.22; 2.02) 0.115 Week 8 3.55 (0.35) 3.42 (0.37) 0.11 (-1.12; 1.34) 0.860 3.83 (0.35) 0.42 (-0.75; 1.60) 0.477 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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