Zsa Zsa Weerts

Efficacy and safety of peppermint oil in IBS 147 7 threshold for the abdominal pain response was included, with a responder being a patient with at least 50% decrease in worst daily abdominal pain in at least four weeks. Primary efficacy outcomes were also evaluated according to IBS subtype as secondary outcomes. Treatment adherence was quantified by counting returned capsules at the study end-visit. Patients were deemed adherent if at least 80% of study medication was taken during the treatment period or until discontinuation of the study. Compliance rate to the digital diary was defined by percentage of entry days completed during the treatment period or until discontinuation with the study. Safety assessment Safety was assessed by the incidence, nature, and severity of AEs occurring during the treatment period. Researchers documented AEs during all telephone follow-up moments (week 2, 4, and 6) and during the end-visit at week 8. In addition, participants were asked to report AEs in the digital symptom diary. Statistical analysis The sample size calculation was based on the most recent meta-analysis 35 available at the time of study design, indicating that 57% of the peppermint oil group had abdominal pain improvement (versus no improvement), compared with 27% in the placebo group. A sample size of 42 in both the placebo and the small-intestinal release peppermint oil group was required to detect a 30% efficacy difference between groups, with a power of 80% at the two-sided 0.05 -level. Anticipating that ileocolonic release would increase efficacy, the same sample of 42 was chosen to compare this group with placebo. To account for heterogeneity, an inflation factor of 1.23 was applied. 36 To account for a 13% dropout, an additional 1.15 inflation factor was applied. Therefore, 60 patients per group were required. All analyses were based on the intention-to-treat (ITT) principle, with correction for the minimization variables sex, inclusion center, IBS-subtype, and age. The responder outcomes were analyzed using multiple logistic regression. Odds Ratios (OR), two-sided 95% confidence intervals (CI), and corresponding P -values are reported. Patients with fewer than four weekly diary entries were considered “non-responders” for that week, regardless of their score. To account for multiple comparisons (both intervention groups with placebo and two primary outcomes), two-sided P -values of ≤0.05/4=0.0125 were considered statistically significant for the primary outcomes.