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Efficacy and safety of peppermint oil in IBS 155 7 significantly between groups ( Table 7. 2). Apart from a few significant changes at single time-points, there were no sustained differences between groups with regard to nausea, abdominal bloating, urgency, or comorbid anxiety and depression ( Supplementary Table S7.4 ). All treatment groups showed improvements in quality of life that persisted over time, without a significant difference between groups ( Supplementary Table S7.4 ). No significantly different changes were observed in stool consistency and frequency across treatment groups apart from a single time point in stool consistency (week 6, Supplementary Table S7.5 ). When analyzing consistency and frequency for each IBS subtype separately, no significant changes were found apart from an increased stool consistency in IBS-D at a single time point (week 6 in the small intestinal peppermint oil group, week 3 in the ileocolonic release peppermint oil group, Supplementary Table S7.6- 7 ). Efficacy outcomes did not differ significantly between primary and secondary/tertiary care patients ( Supplementary Table S7.10, Supplementary Material ). Follow-up measurements until six-months after cessation of treatment also showed no significant differences between placebo and both forms of peppermint oil ( Supplementary Table S7.4 ). Adverse events/safety results Table 7.3 summarizes the AEs reported during the treatment period. No serious adverse events or deaths were reported. In both peppermint oil groups, the total number of AEs was significantly higher compared with placebo (mean (SE) 4.26 (0.37) for small-intestinal release ( P =0.012) and 4.54 (0.45) for ileocolonic release peppermint oil ( P =0.001), versus 2.78 (0.34) for placebo). The most common adverse events were heartburn or GERD symptoms, belching (with and without a minty taste), and headache in small-intestinal release peppermint oil and an altered anal sensation or sensitive urethra, headache and abdominal cramps in ileocolonic release peppermint oil. Concerning belching, in the first two weeks of treatment, the small-intestinal release peppermint oil group had a larger increase in belching from baseline, compared to placebo ( P <0.001 at week one, P =0.023, at week two). Severity of this symptom, however, returned to pre-treatment level after three weeks until the end of treatment, ( Supplementary Figure S7.6 ). More patients on peppermint oil versus placebo discontinued treatment due to adverse events (three in the small-intestinal peppermint oil group (4.8%) and five in the ileocolonic release peppermint oil group (7.9%), compared with one in the placebo group (1.6%)).