Dataset Information

Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain.

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_last ) data were available in 29 of 30 participants. A direct linear relationship (apparent dose-proportionality for systemic menthol exposure) was observed between PMO dose and menthol systemic exposure with mean elimination half-life 2.1, 3.5 and 4.6 hours for the 180, 360 and 540 mg doses, respectively. WMC technical issues precluded complete motility data in all participants. Colonic transit time was inversely related to AUC_last (P = .003); transit time in other regions was not affected. In contrast, stomach, small bowel and whole gut (but not colonic) contractility positively correlated with menthol AUC_last (P < .05).

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.

SUBMITTER: Shulman RJ

PROVIDER: S-EPMC8863319 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain.

Shulman Robert J RJ Chumpitazi Bruno P BP Abdel-Rahman Susan M SM Garg Uttam U Musaad Salma S Kearns Gregory L GL

British journal of clinical pharmacology 20211019 3

<h4>Aims</h4>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.<h4>Methods</h4>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 coate ...[more]

PMID: 34528282

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Project description:BackgroundAn association has been shown between functional abdominal pain disorders (FAPDs) and asthma. However, the exact reason for this association is obscured. The main objective of this study is to identify the possible underlying pathophysiological mechanisms for the association between FAPDs and asthma using gastric motility and lung function tests.MethodsThis was a cross-sectional comparative study that consisted of four study groups. Twenty-four children (age 7-12 years) each were recruited for four study groups; asthma only, FAPDs only, both asthma and FAPDs, and healthy controls. Asthma was diagnosed using the history and bronchodilator reversibility test. The diagnosis of FAPDs was made using Rome IV criteria. All subjects underwent ultrasound assessment of gastric motility and pulmonary function assessment by spirometry, using validated techniques.ResultsAll gastric motility parameters, gastric emptying rate, amplitude of antral contraction, and antral motility index, were significantly impaired in children with FAPDs only, children with asthma only, and children with both asthma & FAPDs, compared to controls (p<0.05). Pulmonary function parameters indicating airway obstruction (FEV1/FVC ratio, peak expiratory flow rate, FEF25-75%) were not impaired in children with FAPDs only compared to controls (p>0.05), but significantly impaired in children with asthma and children with both disorders. Antral motility index correlated with the FEV1/FVC ratio (r = 0.60, p = 0.002) and FEF25%-75% (r = 0.49, p = 0.01) in children with both asthma and FAPDs.ConclusionsGastric motor functions were significantly impaired in children with asthma, children with FAPDs, and children with both disorders. Motility index, measuring overall gastric motor activity, showed a significant positive correlation with lung function parameters that measure airflow limitation. Therefore, these diseases might arise as a result of primary disturbance of smooth muscle activity in the airways and gastrointestinal wall, which could be a possible pathophysiological mechanism for this association between asthma and FAPDs.

Dataset Information

Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain.

Aims

Methods

Results

Conclusion

Publications

Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain.

Similar Datasets

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