Zsa Zsa Weerts

Chapter 7 156 Table 7.3 Summary of treatment emerging adverse events (ITT-population). Placebo Small-intestinal release Peppermint oil Ileocolonic release Peppermint oil N =64 N =62 N =63 Total different AEs , mean (SE) 2.78 (0.34) 4.26 (0.37)* 4.45 (0.45) # AEs ± , , mean frequency (SE) / N (%) Headache 1.56 (0.40) / 21 (32.8) 2.34 (0.59) / 25 (40.3) 2.17 (0.65) / 26 (41.3) Heartburn/GERD symptoms 0.61 (0.16) / 18 (28.1) 2.84 (0.88) / 31 (50.0) 1.81 (0.60) / 23 (36.5) Nausea 1.91 (0.78) / 23 (35.9) 1.45 (0.78) / 16 (25.8) 2.21 (0.77) / 18 (28.6) Belching 1.03 (0.36) / 15 (23.4) 3.71 (1.04) / 28 (45.2) 0.56 (0.21) / 12 (19.0) Belching with/or minty taste 0.02 (0.02) / 1 (1.6) 4.68 (0.99) / 36 (58.1) 0.51 (0.16) / 14 (22.2) Abdominal cramps 0.55 (0.22) / 12 (18.8) 1.42 (0.51) / 13 (21.0) 3.76 (0.99) / 29 (46.0) Altered anal sensation and/or sensitive urethra 0.55 (0.27) / 9 (14.1) 1.48 (0.45) / 22 (35.5) 3.60 (0.95) / 39 (61.9) Peppermint oil scent stool 0.02 (0.02) / 1 (1.6) 0.69 (0.22) / 18 (29.0) 2.02 (0.83) / 18 (28.6) AEs leading to discontinuation , total N Headache, N Palpitations, N Diarrhea and abdominal cramps, N Combination ¶ , N Combination ‡ , N Combination § , N 1 0 1 0 0 0 0 3 1 0 0 1 1 0 5 0 0 1 2 0 2 AE adverse event; SE standard error; GERD Gastroesophageal Reflux Disease. ± Occurrence of AEs was self-reported in the daily symptom diary. The total number of different AEs for small-intestinal release compared with placebo was significantly higher * P =0.012, as well as for ileocolonic release peppermint oil compared with placebo # P =0.001; ¶ Combination of i.e. flatulence, bloating, abdominal pain; ‡ Combination of i.e. headache, tightness of the chest, belching, bloating, muscle cramp; § Combination of i.e. diarrhea, abdominal cramps, altered anal sensation, belching, altered taste.