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A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms.

Abstract

BACKGROUND

Peppermint oil (PO) has shown promise as an IBS therapy, but previous trials have demonstrated variable efficacy and tolerability results.

AIMS

To 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.

METHODS

This 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.

RESULTS

Seventy-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.

CONCLUSIONS

A novel PO formulation designed for sustained release in the small intestine is a safe, effective treatment capable of providing rapid relief of IBS symptoms.

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  • Authors+Show Affiliations

    ,

    Division of Gastroenterology, University of South Alabama, 6000 University Commons, 75 University Blvd, S, Mobile, AL, 36688, USA. bcash@health.southalabama.edu.

    ,

    Digestive Disorders Associates, 621 Ridgely Ave, #201, Annapolis, MD, 21401, USA. michael.epstein@dda.net.

    IM HealthScience LLC, 101 Plaza Real South, Ste 205-S, Boca Raton, FL, 33432, USA. sshah@imhealthscience.com.

    Source

    Digestive diseases and sciences 61:2 2016 Feb pg 560-71

    MeSH

    Adult
    Double-Blind Method
    Female
    Humans
    Irritable Bowel Syndrome
    Male
    Middle Aged
    Parasympatholytics
    Plant Oils

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26319955

    Citation

    Cash, Brooks D., et al. "A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms." Digestive Diseases and Sciences, vol. 61, no. 2, 2016, pp. 560-71.
    Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Dig Dis Sci. 2016;61(2):560-71.
    Cash, B. D., Epstein, M. S., & Shah, S. M. (2016). A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences, 61(2), pp. 560-71. doi:10.1007/s10620-015-3858-7.
    Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Dig Dis Sci. 2016;61(2):560-71. PubMed PMID: 26319955.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. AU - Cash,Brooks D, AU - Epstein,Michael S, AU - Shah,Syed M, Y1 - 2015/08/29/ PY - 2015/06/23/received PY - 2015/08/19/accepted PY - 2015/8/31/entrez PY - 2015/9/1/pubmed PY - 2016/6/2/medline KW - Abdominal pain KW - Bloating KW - Diarrhea KW - Irritable bowel syndrome KW - L-menthol KW - Peppermint oil SP - 560 EP - 71 JF - Digestive diseases and sciences JO - Dig. Dis. Sci. VL - 61 IS - 2 N2 - BACKGROUND: Peppermint oil (PO) has shown promise as an IBS therapy, but previous trials have demonstrated variable efficacy and tolerability results. AIMS: To 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. METHODS: This 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. RESULTS: Seventy-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. CONCLUSIONS: A novel PO formulation designed for sustained release in the small intestine is a safe, effective treatment capable of providing rapid relief of IBS symptoms. SN - 1573-2568 UR - https://www.unboundmedicine.com/medline/citation/26319955/full_citation L2 - https://doi.org/10.1007/s10620-015-3858-7 DB - PRIME DP - Unbound Medicine ER -