Zsa Zsa Weerts

Chapter 7 172 Table S7.4 (continued) 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 Anxiety # Baseline Week 8 Month 6* 6.83 (0.69) 6.48 (0.68) 6.57 (0.69) 5.33 (0.71) 4.45 (0.71) 5.81 (0.71) - -0.53 (-1.55; 0.49) 0.71 (-0.50; 1.91) - 0.304 0.250 6.54 (0.69) 5.07 (0.69) 6.00 (0.69) - -1.12 (-2.14; -0.10) -2.66 (-1.48; 0.94) - 0.031 0.664 Depression # Baseline Week 8 Month 6* 8.05 (0.71) 6.11 (0.71) 7.05 (0.76) 7.58 (0.73) 5.78 (0.73) 7.39 (0.79) - -0.73 (-1.78; 0.32) 0.79 (-0.50; 2.09) - 0.170 0.228 7.63 (0.71) 6.11 (0.71) 7.28 (0.77) - -0.46 (-1.51; 0.59) 0.68 (-0.62; 1.98) - 0.391 0.303 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. The absolute uncorrected change from baseline within treatment groups, i.e. not the difference in change compared to placebo, can be calculated using the given estimated means. 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). The follow-up period consisted of six months without treatment. § Assessed daily during the pre-treatment and treatment period using an 11-point NRS in the digital diary: 0 = no symptoms, 10 = worst possible pain; ± Assessed weekly during the pre-treatment period and treatment period using an 11-point NRS in the digital diary: 0 = no symptoms, 10 = worst imaginable symptoms; † Assessed using the IBS-SSS questionnaire consisting of 5-items with each a maximum score of 100 (scored on a visual analogue scale); severity of pain, duration of pain, severity of abdominal distention, dissatisfaction with bowel habits, and disruption in quality of life; µ Assessed using the IBS-QoL questionnaire consisting of 34-items with a 5-point Likert scale: 1 = good quality of life, 5= worse quality of life; ♮ Assessed using the EQ-5D-5L questionnaire that measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Dutch social tariffs were used to transform raw EQ-5D-5L scores to utility scores 37 , which vary from a completely healthy state (1) to a state of death (0); # Anxiety was assessed using the GAD-7 questionnaire consisting of 7-items with a 4-point response scale: 0 = not at all, 3 = almost every day. Depression was assessed using the PHQ-9 questionnaire consisting of 9-items with a 4-point response scale: 0 = not at all, 3 = almost every day; * Values for the six months follow-up were obtained from the corrected model for the treatment period including six months follow-up, all other values are obtained from the corrected model for the eight-week treatment period.