Zsa Zsa Weerts

Chapter 7 150 Table 7.1 (continued) Placebo Small-intestinal release Peppermint oil Ileocolonic release Peppermint oil N =64 N =62 N =63 IBS Quality of Life, mean score (SD) µ 74.0 (14.2) 72.2 (14.7) 72.8 (16.6) EQ-5D-5L, mean utility score (SD) ♮ 0.72 (0.2) 0.74 (0.2) 0.74 (0.2) Psychological comorbidities # Anxiety, mean (SD) 6.0 (4.4) 4.5 (3.9) 5.7 (4.6) Depression, mean (SD) 7.0 (4.7) 6.6 (4.4) 6.7 (4.6) BMI body mass index in kg/m 2 ; IBS Irritable Bowel Syndrome. ¶ Self-reported race; placebo, N =1 mixed race is 1/4 th Asian; small-intestinal release peppermint oil, N =1 mixed race is 1/4 th Asian, and N =1 mixed race is 1/2 nd unknown; ileocolonic release peppermint oil, N =4 mixed race is 1/4 th Asian, and N =1 mixed race was 1/2 nd Asian; ‡ Determined in a face-to-face interview (Rome IV); § Assessed daily during the pre-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 using an 11-point NRS in the digital diary: 0=no symptoms, 10=worst imaginable symptoms; † The IBS-SSS consists of 5-items with a maximum score of 100, higher scores indicate more severe symptoms; µ The IBS-QoL consists of 34-items with a 5-point Likert scale: 1=good, 5=worse quality of life; ♮ The EQ-5D-5L measures 5-dimensions of QoL. Raw scores are transformed to utility scores 31 , which vary from 1 (perfect health) to 0 (death); # Anxiety, the GAD-7 consists of 7-items, and depression, the PHQ-9 consists of 9-items, both with a 4-point response scale, 0=not at all, 3=almost every day. Primary efficacy outcomes The proportion of abdominal pain responders did not differ significantly between groups: 46.8% in small-intestinal release peppermint oil (OR1.68; 95% CI0.80, 3.51; P =0.170; number needed to treat (NNT) 8.1) and 41.3% in ileocolonic release peppermint oil (OR1.39; 95%CI 0.66, 2.90; P =0.385; NNT 14.5), compared with 34.4% in placebo ( Table 7.2, Supplementary Table S7.2, Figure 7.1 ). The proportion of global relief responders did also not differ significantly between groups: 9.7% in small-intestinal release peppermint oil (OR2.12; 95%CI 0.49, 9.17; P =0.317), and 1.6% in ileocolonic release peppermint oil (OR0.33; 95%CI 0.03, 3.35; P =0.351), compared with 4.7% in placebo ( Table 7.2, Figure 7.1 ). In the PP-analysis, the primary endpoints did not differ significantly between groups ( Supplementary Table S7.3). No significant differences in primary efficacy outcomes were observed for each IBS- subtype separately ( Supplementary Table S7.9 ).