Peppermint Oil

證據等級: L5

預測適應症: 10 個

Peppermint Oil: From No Registered Indication to Cardiovascular Disease (Exploratory)

One-Sentence Summary

Peppermint Oil (DrugBank DB11198) has no approved indication on record and is not currently marketed in Taiwan. Among 10 TxGNN-predicted indications, the only one with any supporting clinical or literature evidence is Cardiovascular Disease, backed by 2 completed early-phase human trials (n=36–40), 1 ongoing RCT protocol, and 6 relevant publications — evidence level L3. Note: the model’s single highest-scoring prediction (leprosy) and several others (pneumocystosis, coronary artery disease, myocardial ischemia, various polyp indications) currently have zero supporting trials or literature and are algorithmic associations only.

Quick Overview

Item	Content
Original Indication	Not available — no approved indication on record; drug not marketed in Taiwan
Predicted New Indication	Cardiovascular Disease
TxGNN Prediction Score	99.13% (rank 9 of 10 by score, but the only prediction with real-world evidence)
Evidence Level	L3
Taiwan Market Status	✗ Not Marketed
Number of NDAs	0
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available for peppermint oil as a whole product. Based on the evidence pack, the working hypothesis relies on menthol — its principal constituent — acting as a TRPM8/TRPA1 receptor agonist with known smooth-muscle-relaxant and vagal (parasympathetic) activating effects. One physiological study (PMID 30070742) found that gastric cooling and menthol stimulation increase cardiac parasympathetic efferent activity in healthy volunteers, providing a plausible mechanistic route from a gastrointestinal-acting compound to cardiovascular autonomic modulation.

Because no original approved indication exists in this evidence pack, the relationship between “original use” and “predicted new indication” cannot be formally established. What is available instead is early human interventional data: two completed, small, non-randomized (Phase NA) studies testing oral peppermint on blood pressure and cardiometabolic parameters, plus a newly registered placebo-controlled RCT protocol (PMID 40333716) specifically designed to test peppermint oil in pre-/stage-1 hypertension. This progression — mechanism study → small open-label studies → registered RCT — is why cardiovascular disease reaches decision stage S1 while the model’s top-ranked prediction (leprosy) and most others remain at S0 with no evidence at all.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT05561543	N/A	Completed	40	Tested effects of oral peppermint on cardiometabolic outcomes in participants with mild–moderate hypertension; builds on prior trial showing peppermint improved systolic BP and lipids in healthy individuals
NCT05071833	N/A	Completed	36	Tested oral peppermint supplementation’s effect on cardiometabolic parameters; first randomized follow-up to earlier non-randomized findings

Note: A third trial (NCT04966546, chronic subdural hematoma post-op) appeared in the evidence pack but was graded low-relevance (C) and withdrawn with zero enrollment — excluded here as not informative for this indication.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
40333716	2025	RCT Protocol	PLoS ONE	Protocol for a placebo-controlled RCT testing peppermint oil (menthol/flavonoid-rich) in pre- and stage-1 hypertension
30070742	2018	Mechanism Study	Experimental Physiology	Gastric cooling and menthol stimulation increase cardiac parasympathetic efferent activity in healthy adults
25037671	2014	Review	Explore (NY)	Broad CAM review citing peppermint oil’s established use for irritable bowel syndrome
19198983	2009	Review	Internal and Emergency Medicine	General practice/cardiovascular medicine evidence update (abstract not available)
27277875	2016	Pharmacokinetic/Analytical	Bioanalysis	Real-time breath monitoring after oral peppermint capsule ingestion; tracked menthone rise and fall over 10 hours
17577363	2007	Case Report	Contact Dermatitis	Allergic contact dermatitis reaction to a topical peppermint foot spray (safety signal, non-cardiovascular)

US Market Information

Peppermint oil currently holds zero licenses/NDAs in the Taiwan regulatory dataset and is marked 未上市 (Not Marketed). No approved indication text, dosage form, or brand information is available in this evidence pack.

Safety Considerations

No safety data (key warnings, contraindications, or drug interactions) is currently available — all fields in the evidence pack are flagged as data gaps, and the drug interaction query returned no results. Because peppermint oil is not marketed in Taiwan, no local package insert exists to reference. This is recorded as a Blocking data gap (DG001) that must be resolved before any formal safety assessment (S1) can be completed.

Conclusion and Next Steps

Decision: Hold

Rationale:

Evidence is limited to two small (n=36–40), non-randomized/open-label studies and one not-yet-completed RCT protocol — insufficient for a Go decision at L3.
The model’s highest-scoring predictions (leprosy, pneumocystosis, coronary artery disease, etc.) have no clinical or literature support whatsoever and should not be prioritized over cardiovascular disease.
A Blocking data gap on TFDA/regulatory warnings (DG001) prevents any formal safety sign-off regardless of efficacy evidence.

To proceed, the following is needed:

Results from the ongoing/protocol-stage RCT (PMID 40333716) once completed
Confirmed mechanism of action (MOA) documentation from DrugBank (DG002)
TFDA (or equivalent) label warnings/contraindications and drug interaction data (DG001)
A larger, adequately powered randomized controlled trial specifically in cardiovascular disease or hypertension populations
Reassessment of whether the top TxGNN-scored predictions (e.g., leprosy) warrant continued tracking, or should be deprioritized given the complete absence of supporting evidence
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.