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Efficacy and safety of peppermint oil in IBS 173 7 Table S7.5 Stool frequency and stool consistency (ITT-population). Measurement Placebo N =64 Small-intestinal release Peppermint oil N =62 Ileocolonic release Peppermint oil N =63 Estimated means (SE) Estimated means (SE) Treatment effect (95% CI) P -value Estimated means (SE) Treatment effect (95% CI) P -value Frequency scores § Baseline 9.10 (0.75) 9.38 (0.76) - - 8.55 (0.75) - - Week 1 9.23 (0.67) 9.81 (0.68) 0.30 (-1.11; 1.71) 0.675 9.00 (0.68) 0.32 (-1.08; 1.74) 0.649 Week 2 7.69 (0.66) 8.45 (0.66) 0.48 (-1.36; 2.33) 0.607 6.63 (0.66) -0.50 (-2.35; 1.34) 0.591 Week 3 6.80 (0.58) 7.91 (0.59) 0.83 (-1.21; 2.88) 0.423 6.50 (0.58) 0.25 (-1.78; 2.28) 0.807 Week 4 6.75 (0.66) 7.26 (0.67) 0.23 (-2.09; 2.54) 0.847 6.48 (0.67) 0.28 (-2.03; 2.60) 0.810 Week 5 6.50 (0.59) 6.74 (0.61) -0.04 (-2.38; 2.31) 0.975 5.60 (0.61) -0.34 (-2.68; 2.00) 0.776 Week 6 5.55 (0.66) 5.95 (0.66) 0.12 (-2.40; 2.65) 0.923 5.56 (0.68) 0.56 (-1.98; 3.10) 0.664 Week 7 5.49 (0.52) 5.02 (0.53) -0.75 (-3.14; 1.64) 0.538 4.58 (0.56) -0.36 (-2.76; 2.05) 0.770 Week 8 4.06 (0.42) 4.66 (0.42) 0.32 (-1.97; 2.62) 0.783 4.00 (0.45) 0.49 (-1.82; 2.80) 0.678 Stool consistency ± Baseline 4.10 (0.16) 3.97 (0.16) - - 4.30 (0.16) - - Week 1 4.06 (0.16) 4.15 (0.16) 0.23 (-0.13; 0.60) 0.212 4.49 (0.16) 0.24 (-0.13; 0.60) 0.202 Week 2 4.15 (0.16) 4.20 (0.16) 0.18 (-0.21; 0.56) 0.366 4.47 (0.16) 0.12 (-0.27; 0.50) 0.551 Week 3 4.17 (0.16) 4.25 (0.17) 0.22 (-0.19; 0.62) 0.291 4.44 (0.17) 0.08 (-0.32; 0.48) 0.704 Week 4 4.08 (0.17) 4.15 (0.17) 0.21 (-0.21; 0.62) 0.335 4.55 (0.17) 0.28 (-0.14; 0.70) 0.197 Week 5 4.14 (0.16) 4.34 (0.17) 0.33 (-0.09; 0.76) 0.124 4.66 (0.17) 0.33 (-0.10; 0.75) 0.129 Week 6 4.14 (0.16) 4.53 (0.16) 0.52 (0.09; 0.95) 0.018 4.61 (0.17) 0.27 (-0.16; 0.71) 0.219 Week 7 4.22 (0.16) 4.31 (0.17) 0.23 (-0.22; 0.68) 0.325 4.85 (0.18) 0.43 (-0.03; 0.89) 0.065 Week 8 4.27 (0.17) 4.29 (0.17) 0.16 (-0.32; 0.63) 0.520 4.62 (0.18) 0.16 (-0.32; 0.64) 0.517 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 (SBMs) per week. A general decrease in SBMs was found over time ( Baseline 9.10 - Week 8 4.06, F30.03, P <0.000). This reduction in registration of bowel movements was seen among all subtypes and we hypothesize that this is due to logging fatigability rather than an actual decrease in stool frequency; ± 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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