13 May Novel Peppermint Oil Formulation Designed To Control Irritable Bowel Symptoms
MedicalResearch.com Interview with:
Brooks D. Cash, MD
Chief, Gastroenterology Division
Professor of Medicine
University of South Alabama
Mobile, AL 36688
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Irritable bowel syndrome (IBS) is a chronic functional disorder characterized by multiple symptoms including, but not limited to, abdominal pain or discomfort, constipation, diarrhea, urgency of bowel movement (BM), a sensation of incomplete evacuation, pain at evacuation, abdominal bloating, and passage of gas or mucus. IBS can be classified into four primary subtypes: mixed IBS (IBS-M), diarrhea-predominant IBS (IBS-D), constipation-predominant IBS (IBS-C), and unsubtyped IBS (IBS-U). Among adult patients with IBS, a sizeable proportion suffers from IBS-M, with prevalence rates among IBS patients estimated to be between 44% to 66%. Because of the variability in symptoms associated with IBS-M and the lack of effective or approved therapies, clinicians often face challenges in managing this common IBS subtype.
PO and its active ingredient, l-Menthol, are kappa opioid agonists, possess smooth muscle calcium channel antagonist and serotonergic (5HT3) antagonist properties, and exert anti-inflammatory, anti-infective, and carminative effect. A recent meta-analysis of medical therapies for IBS found that PO had the lowest number needed to treat among the various options evaluated. The previously published IBS Reduction Evaluation and Safety Trial (IBSREST) showed that PO-SST, a novel formulation of PO using solid-state microspheres to target delivery to the small intestine, was an effective IBS therapy at 24 hours, with improved efficacy at 4 weeks in a combined group of IBS-M and IBS-D patients. In view of the unmet need in IBS-M, we performed a post hoc analysis of the effects of PO-SST among only the IBS-M patients from the IBSREST trial.
MedicalResearch.com: What should readers take away from your report?
Response: Our results indicate that this formulation of PO provided superior improvement from baseline compared with placebo in the mean Total IBS Symptom Score (TISS), the mean frequency of IBS symptoms, and multiple individual IBS symptoms, including constipation, in patients with IBS-M.
After 4 weeks of treatment, patients with IBS-M who received PO-SST demonstrated statistically significant reduction (improvement) of 43% in the mean TISS from baseline compared with 24% in patients randomized to receive placebo (P = 0.0298). Similarly, the mean reduction in the frequency of IBS symptoms of 37% was significantly greater in the PO-SST group compared with 18% reduction observed in the placebo group (P = 0.0349). The 51% reduction in the mean intensity of IBS symptoms for patients receiving PO-SST was numerically superior to the 33% reduction in patients receiving placebo (P = 0.0528). In the case of the average of frequency and intensity, and mean frequency scores, the data reached a statistically significant difference between the PO-SST treatment group and the placebo group (P < 0.05).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Additional prospective evaluation of PO in patients with IBS-M are needed. In addition, more research regarding the varied mechanisms of action of PO would possibly allow clinicians to more accurately predict who might respond to this therapy.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Disclosures: Dr. Cash has served as a consultant to IM Health Sciences, the company that markets PO-SST.
In Patients with Irritable Bowel Syndrome-Mixed (IBS-M), a Novel Peppermint Oil Formulation Designed for Site Specific Targeting (PO-SST), in the Small Intestine, Improves the 8 Symptoms that Comprise the Total IBS Symptoms Score
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