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Efficacy and safety of peppermint oil in IBS 151 7 Table 7.2 Responder endpoints (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, 30% ¶ Global relief ‡ 22 (34.4) 3 (4.7) 29 (46.8) 6 (9.7) 0.170 0.317 1.68 (0.80 – 3.51) 2.12 (0.49 – 9.17) 26 (41.3) 1 (1.6) 0.385 0.351 1.39 (0.66 – 2.90) 0.33 (0.03 – 3.35) Secondary endpoints Moderate relief § 13 (20.3) 24 (38.7) 0.030 2.47 (1.09 – 5.56) 13 (20.6) 0.980 0.99 (0.41 - 2.38) Abdominal pain, 50% # 8 (12.5) 16 (25.8) 0.062 2.51 (0.96 – 6.59) 13 (20.6) 0.220 1.85 (0.69 – 4.96) P- values, ORs and corresponding two-sided 95% confidence intervals were calculated using multiple logistic regression adjusted for minimization variables. ¶ A responder was a patient with at least 30% decrease in mean worst daily abdominal pain in at least 4 out of 8 weeks (FDA-recommendation); ‡ A responder was a patient with at least a global relief score of 6 or 7 (on a 7-point NRS) in at least 4 out of 8 weeks (EMA-recommendation); § A responder was a patient with at least a global relief score of 5, 6, or 7 (on a 7-point NRS) in at least 4 out of 8 weeks; # A responder was a patient with at least 50% decrease in mean worst daily abdominal pain in at least 4 out of 8 weeks.