TY - JOUR
T1 - Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome
AU - Weerts, Zsa Zsa R.M.
AU - Masclee, Ad A.M.
AU - Witteman, Ben J.M.
AU - Clemens, Cees H.M.
AU - Winkens, Bjorn
AU - Brouwers, Jacobus R.B.J.
AU - Frijlink, Henderik W.
AU - Muris, Jean W.M.
AU - De Wit, Niek J.
AU - Essers, Brigitte A.B.
AU - Tack, Jan
AU - Snijkers, Johanna T.W.
AU - Bours, Andrea M.H.
AU - de Ruiter-van der Ploeg, Annieke S.
AU - Jonkers, Daisy M.A.E.
AU - Keszthelyi, Daniel
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Background & Aims: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal–release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. Methods: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal–release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. Results: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal–release peppermint oil group had a response (46.8%, P =. 170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P =. 385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P =. 317 and 1.6%, P =. 351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P =. 016), discomfort (P =. 020), and IBS severity (P =. 020). Adverse events, although mild, were more common in both peppermint oil groups (P <. 005). Conclusions: In a randomized trial of patients with IBS, we found that neither small-intestinal–release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal–release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.
AB - Background & Aims: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal–release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. Methods: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal–release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. Results: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal–release peppermint oil group had a response (46.8%, P =. 170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P =. 385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P =. 317 and 1.6%, P =. 351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P =. 016), discomfort (P =. 020), and IBS severity (P =. 020). Adverse events, although mild, were more common in both peppermint oil groups (P <. 005). Conclusions: In a randomized trial of patients with IBS, we found that neither small-intestinal–release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal–release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.
KW - Functional Gastrointestinal Disorder
KW - PERSUADE Study
KW - RCT
KW - Treatment
U2 - 10.1053/j.gastro.2019.08.026
DO - 10.1053/j.gastro.2019.08.026
M3 - Article
C2 - 31470006
AN - SCOPUS:85075994265
SN - 0016-5085
VL - 158
SP - 123
EP - 136
JO - Gastroenterology
JF - Gastroenterology
IS - 1
ER -