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Efficacy and safety of peppermint oil in IBS 183 7 Table S7.9 Primary endpoints per IBS-subtype (ITT-population). Placebo N =64 Small-intestinal release Peppermint oil N =62 Ileocolonic release Peppermint oil N =63 No. responders (%) No. responders (%) P- value Odds Ratio (95% CI) No. responders (%) P- value Odds Ratio (95% CI) Primary endpoints Abdominal pain ¶ IBS-D IBS-C IBS-M IBS-U Global relief ‡ IBS-D IBS-C IBS-M IBS-U 11/29 (37.9) 6/14 (42.9) 3/12 (25.0) 2/9 (22.2) 1/19 (3.4) 1/14 (7.1) 1/12 (8.3) 0/9 (0) 10/25 (40.0) 5/12 (41.7) 7/15 (46.7) 7/10 (70.0) 1/25 (4.0) 1/12 (8.3) 2/15 (13.3) 2/10 (20.0) 0.985 0.905 0.278 0.070 0.887 0.986 0.798 0.999 0.99 (0.32 – 3.08) 0.90 (0.17 – 4.81) 2.62 (0.46 – 14.87) 8.06 (0.84 – 77.12) 1.24 (0.07 – 23.75) 1.03 (0.05 – 21.25) 1.44 (0.09 – 23.43) N.A. 9/29 (31.0) 10/16 (62.5) 4/13 (30.8) 3/5 (60.0) 1/29 (3.4) 0/16 (0) 0/13 (0) 0/5 (0) 0.444 0.114 0.931 0.135 0.958 0.998 0.999 1.000 0.65 (0.65 – 1.98) 3.80 (0.73 – 19.90) 0.92 (0.12 – 6.76) 7.28 (0.54 – 98.64) 0.93 (0.05 – 16.70) N.A. N.A. N.A. ¶ A responder was defined as a patient with at least 30% decrease in mean worst daily abdominal pain in at least 50% of weeks in which treatment was given (FDA- recommendation); ‡ A responder was defined as a patient with at least a global relief score of 6 or 7 (on a 7-point NRS) in at least 50% of weeks in which treatment was given (EMA-recommendation).