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Chapter 7 154 0 2 4 6 8 150 200 250 300 350 Weeks IBS Symptom Severity System score Placebo Small-intestinal release peppermint oil Ileocolonic release peppermint oil * NS A significantly greater improvement in IBS symptom severity was found among those treated with small-intestinal release peppermint oil, with a corrected difference in change from baseline of -41.8 on the IBS-SSS total score (-91.5 versus -49.8 for small intestinal release versus placebo; 95%CI for difference -76.88, -6.70; P =0.020) at week eight ( Figure 7.3, Supplementary Table S7.4 ). A greater percentage of the small-intestinal release peppermint oil group reported a symptom relief score of at least 5 (moderate relief ) in at least four treatment weeks (38.7%, P =0.030, non-significant), compared with placebo (20.3%) ( Table 7. 2 , Supplementary Figure S7. 3). In addition, both peppermint oil groups reported using rescue medication for pain fewer times than the placebo group, i.e. on average 3.71 ( P =0.087), 3.16 ( P =0.039), and 5.16 times for small-intestinal release, ileocolonic release peppermint oil, and placebo, respectively ( Supplementary Table S7.8 ). However, this did not reach the pre-specified level of significance ( =0.025). Figure 7.3 IBS-SSS in the ITT-population ( N =189). Values are adjusted estimated marginal means derived from the linear mixed model, bars represent standard errors. The small-intestinal peppermint oil group had significantly more reduction in IBS severity at the end of the eight-week treatment period. * P =0.020. The absolute change from baseline in small-intestinal release peppermint oil was -91.53 points. The Ileocolonic release peppermint oil group did not differ significantly in severity reduction compared with placebo ( P =0.053). Assessed using the IBS-SSS questionnaire consisting of 5-items with each a maximum score of 100. Ileocolonic release peppermint oil did not yield significantly more relief, reduction in abdominal discomfort or abdominal pain, nor improvement in IBS severity over placebo ( Supplementary Table S7.4 ). When using a larger abdominal pain decrease threshold, i.e. 50 instead of 30%, the proportion of abdominal pain responders did not differ