Peppermint Oil with Site Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits

Brooks D. Cash, Michael S. Epstein, Syed M. Shah


Background  Among the 3 primary irritable bowel syndrome (IBS) subtypes, the availability of effective therapies for IBS-mixed (IBS-M) remains an unmet clinical need. No therapies are currently approved for patients with IBS-M, despite the fact that this subtype affects a large proportion of IBS patients.

Aims  To evaluate the efficacy of a novel formulation of peppermint oil with site specific targeting (PO-SST) in patients with IBS-M.

Methods  Thirty-four subjects met Rome III criteria for IBS-M and were randomly allocated to receive PO-SST TID (n=16) or identical placebo (n=18) for 4 weeks. The primary analysis was based on the Total IBS Symptom score (TISS). Additional assessments included the change from baseline in both frequency and intensity of individual IBS symptoms.

Results  After 4 weeks of treatment, IBS-M patients in the PO-SST arm demonstrated statistically significant reduction from baseline in the TISS (P = 0.0298) and symptom frequency (P = 0.0349) and reached near-significance (P = 0.0528) in reduction in IBS symptom intensity. For all 8 IBS symptoms evaluated individually, patients in the PO arm had a greater reduction in symptoms compared to placebo, with statistical significance reached for abdominal pain (P = 0.0426), constipation (P = 0.0085), urgency (P = 0.0364), and sense of incomplete evacuation (P = 0.0422).

Conclusions  PO-SST demonstrated statistically significant reduction versus placebo in TISS, abdominal pain, constipation, urgency, and sense of incomplete evacuation in IBS-M patients.


Irritable bowel syndrome, peppermint oil, abdominal pain, constipation, diarrhea, l-Menthol

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