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Efficacy and safety of peppermint oil in IBS 153 7 0 2 4 6 8 0 4 5 6 7 Weeks Worst daily abdominal pain (11-point NRS) Placebo Small-intestinal release peppermint oil Ileocolonic release peppermint oil * NS 0 2 4 6 8 0 3 4 5 6 7 8 Weeks Abdominal discomfort (11-point NRS) Placebo Small-intestinal release peppermint oil Ileocolonic release peppermint oil * * The small-intestinal release peppermint oil was also superior over placebo with respect to abdominal discomfort. This effect appeared at week six of treatment, with corrected differences in change from baseline on an 11-point NRS, when compared with placebo, of -0.95 (95%CI -1.74, -0.15; P =0.020) at six weeks, -0.97 (95%CI -1.71, -0.24; P =0.009) at seven weeks, and -0.69 (95% CI -1.36, -0.03; P =0.041, non-significant as =0.025) at eight weeks ( Figure 7.2, Supplementary Table S7.4) . Figure 7.2 Abdominal pain and discomfort scores 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 mean daily worst abdominal pain compared with placebo at week 8 ( P =0.016). The small-intestinal peppermint oil group also had significantly more reduction in abdominal discomfort compared with placebo, ( P =0.020, P =0.009, and P =0.041 at week 6, 7 and 8 of treatment, respectively). The ileocolonic release peppermint oil group did not differ significantly in reduction in abdominal pain and discomfort compared with placebo. Assessed weekly using an 11-point NRS in the digital diary.

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