A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms
What this study found
The peppermint oil formulation improved global IBS symptoms and several individual symptoms more than placebo, with rapid benefit at 24 hours and sustained benefit through 28 days. Total IBS Symptom Score decreased by 40.0% at 28 days versus 24.3% with placebo (P = 0.0246), and the 24-hour reduction in abdominal pain or discomfort was greater with peppermint oil than placebo (-0.74 vs -0.30; P = 0.0138). At 28 days, peppermint oil also produced larger reductions in abdominal pain or discomfort, bloating or distension, pain at evacuation, and sense of incomplete evacuation, with P values…
- Study & population
- Multicenter placebo-controlled interventional study at four U.S.
- Intervention
- Peppermint oil was given orally as two capsules per dose, 180 mg per dose, three times daily before breakfast, lunch, and dinner for 4 weeks.
- Key limitation
- The treatment period was short at 4 weeks, and the active-arm sample was modest.
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Open PDFOriginal abstract
BackgroundPeppermint oil (PO) has shown promise as an IBS therapy, but previous trials have demonstrated variable efficacy and tolerability results.AimsTo evaluate the efficacy and tolerability of a novel formulation of PO designed for sustained release in the small intestine in patients with IBS-M and IBS-D.MethodsThis is a 4-week, randomized, double-blind, placebo-controlled clinical trial of PO or identical placebo 3 times daily in patients fulfilling Rome III criteria for IBS-M or IBS-D. The primary endpoint was the change from baseline in the Total IBS Symptom Score (TISS) after 4 weeks of treatment.ResultsSeventy-two patients (mean age 40.7 years, 75 % female, 77.8 % white) were randomized to PO (n = 35) or placebo (n = 37). At 4 weeks, PO was associated with a 40 % reduction in the TISS from baseline (mean change −1.16, SD ± 0.807), superior to the 24.3 % decrease (mean change −0.70, SD ± 0.737) observed with placebo (P = 0.0246). The decrease in the TISS of 19.6 % (mean change −0.55, SD ± 0.613) in the PO group at 24 h was also significantly larger than placebo (−10.3 %, mean change −0.27, SD ± 0.342) (P = 0.0092). At trial completion, patients in the PO group experienced greater improvement in multiple individual gastrointestinal symptoms as well as in severe or unbearable symptoms, compared to placebo. PO was well tolerated with few adverse events.ConclusionsA novel PO formulation designed for sustained release in the small intestine is a safe, effective treatment capable of providing rapid relief of IBS symptoms.