Randomised Trial: Peppermint Oil (Menthol) Pharmacokinetics in Children and Effects on Gut Motility in Children with Functional Abdominal Pain

Authors

Robert J Shulman
Bruno P Chumpitazi
Susan M Abdel-Rahman
Uttam Garg
Salma Musaad
Gregory L Kearns

Publication Date

3-1-2022

Journal

British Journal of Clinical Pharmacology

DOI

10.1111/bcp.15076

PMID

34528282

PMCID

PMC8863319

PubMedCentral® Posted Date

3-1-2023

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

Abdominal Pain, Child, Humans, Intestine, Small, Mentha piperita, Menthol, Plant Oils, abdominal pain, contractility, menthol, motility, peppermint oil

Abstract

AIMS: Little is known regarding the pharmacokinetics and pharmacodynamics of menthol, the active ingredient in peppermint oil (PMO). Our aim was to investigate the pharmacokinetics of menthol at 3 dose levels in children and determine their effects on gut motility and transit.

METHODS: Thirty children ages 7-12 years with functional abdominal pain underwent wireless motility capsule (WMC) testing. Approximately 1 week later they were randomized to 180, 360 or 540 mg of enteric coated PMO (10 participants per dose). Menthol pharmacokinetics were determined via blood sampling over 24 hours. They then took their respective dose of PMO (180 mg once, 180 mg twice or 180 mg thrice daily) for 1 week during which time the WMC test was repeated.

RESULTS: Evaluable area under the plasma concentration vs. time curve (AUC

CONCLUSION: Pharmacokinetics and pharmacodynamics of menthol derived from PMO demonstrated apparent dose-proportionality. A higher dose of PMO may be needed to achieve maximal gut response. www.clinicaltrials.gov NCT03295747.