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Randomized trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain: 540 mg vs. 900 mg dose comparison.

  • 2025-05-19
  • British journal of clinical pharmacology 91(9)
    • Robert J Shulman
    • Bruno P Chumpitazi
    • Daniel Gonzalez
    • Uttam Garg
    • Salma Musaad
    • Jiali Wen
    • Gregory L Kearns

Study Design

Type
Randomized Controlled Trial (RCT)
Population
Children 7-12 years of age with functional abdominal pain
Methods
Randomized to 540 mg or 900 mg of oral enteric-coated peppermint oil; wireless motility capsule testing; blood sampling over 24 h for menthol PK
Blinding
Open-label
Duration
1 week
Funding
Unclear

Aims

There is a paucity of information on the pharmacokinetics (PK) and pharmacodynamics (PD) of menthol, the active ingredient in peppermint oil (PMO). We studied the PK of menthol (540 and 900 mg) in children and measured their effects on gut transit/contractility.

Methods

Children 7-12 years of age with functional abdominal pain underwent wireless motility capsule (WMC) testing. One week later, they were randomized to 540 mg or 900 mg of oral enteric-coated PMO. Blood was sampled over 24 h to determine menthol PK. The WMC test was repeated while they took their respective dose (180 mg thrice or 180 mg five times daily) for a week.

Results

Twenty-five children received 540 mg, and 15 received 900 mg (mean age 10.4 ± 1.1 years, 60% female). Peak plasma concentrations (Cmax) were observed at approximately 2.5 h post-dose. There was no evident dose effect for the apparent elimination rate constant, time of peak plasma concentration (Tmax), Cmax, total plasma clearance, nor the apparent volume of distribution. Mean area under the plasma concentration vs. time curve (AUC) for the 900 mg PMO dose cohort was approximately 1.5-fold higher compared with the 540 mg dose; the difference disappeared correcting for dose. Colonic and whole bowel transit time were significantly positively correlated with menthol AUC. The 900 mg (vs. 540 mg) dose decreased colonic (P = 0.002) and whole gut (P = 0.02) contraction frequency.

Conclusions

The PK of menthol derived from PMO demonstrates apparent dose-proportionality, and gut transit and contractility are associated with the systemic concentration of menthol.

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