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Su1373 Ibgard®, a Novel Small Intestine Targeted Delivery System of Peppermint Oil, Results in Significant Improvement in Severe and Unbearable IBS Symptom Intensity. Results From a US Based, 4-Week, Randomized, Placebo-Controlled, Multi-Center Ibsrest™ Trial

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... Antidepressant medications including tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) have been found to be effective for global symptom and pain relief in IBS patients, although adverse effects have occurred that may limit their utility. Peppermint oil formulations also seem to improve pain in IBS [20,21]. In general, fiber is a bulking agent used to firm up stool for patients with IBS-D and to relieve constipation in IBS-C, providing overall relief in IBS [20]. ...
... The number needed to treat was three. In a more recent study using a novel formulation of peppermint designed to provide sustained release in the small bowel, 72 patients with non-constipated IBS defined by the Rome III criteria treated with peppermint oil 180 mg three times a day had a reduced total IBS Symptom Score as well as reduction in individual symptoms such as abdominal pain, bloating, bowel movement urgency compared to placebo over 4 weeks [27]. Notably, there was no significant change in diarrhea, feeling of incomplete evacuation, or gas. ...
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Opinion statement: Irritable bowel syndrome (IBS) is a common gastrointestinal disease characterized by abdominal pain and change in bowel habits. IBS diarrhea predominant (IBS-D), which is arguably the most common subset of IBS, is also associated with rectal urgency, increased frequency, abdominal bloating, and loose to watery stools. Current treatments for diarrhea include mu-opioid agonists (i.e., loperamide, lomotil) and bile acid sequestrants (i.e., cholestyramine) while treatments for abdominal pain include antispasmodics (i.e., hyoscyamine, dicyclomine) and tricyclic antidepressants (i.e., amitriptyline). There are currently 3 FDA-approved treatments for IBS-D, which have been shown to improve both abdominal pain and diarrhea. Alosetron was initially approved by FDA 2000; however, its use is now limited to women with severe IBS-D symptoms refractory to other treatment. Eluxadoline, a mixed mu-opioid agonist, and rifaximin, a broad spectrum gut specific antibiotic, were both FDA approved in 2015. Eluxadoline has been shown to relieve abdominal pain and stool consistency in appropriate candidates. While large trials already showed the efficacy of rifaximin in treating non-constipated IBS for bloating, stool consistency, and abdominal pain, the recent TARGET 3 trial demonstrates that retreatment is also effective. While these new treatments significantly expand options for patients suffering from IBS-D, there is likely to remain a need for additional safe and effective therapies.
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Background Peppermint oil (PO) has intrinsic properties that may benefit patients with irritable bowel syndrome (IBS) symptoms. The study objective was to determine the effect of peppermint oil in the treatment of the IBS. Methods We systematically searched MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (Cochrane CENTRAL), ClinicalTrials.gov, EMBASE (Ovid), and Web of Science for randomized controlled trials (RCTs) of PO for IBS. We appraised the eligible studies by the Cochrane risk of bias tool. We performed random-effects meta-analysis on primary outcomes including global improvement in IBS symptoms and abdominal pain. A PRISMA-compliant study protocol is registered in PROSPERO Register [2016, CRD42016050917]. Results Twelve randomized trials with 835 patients were included. For global symptom improvement, the risk ratio (RR) from seven RCTs for the effect of PO (n = 253) versus placebo (n = 254) on global symptoms was 2.39 [95% confidence interval (CI): 1.93, 2.97], I² = 0%, z = 7.93 (p < 0.00001). Regarding abdominal pain, the RR from six RCTs for the effect of PO (n = 278) versus placebo (n = 278) was 1.78 [95% CI: 1.43, 2.20], I² = 0%, z = 5.23 (p < 0.00001). Overall, there were no differences in the reported adverse effects: PO (32 events, 344 total, 9.3%) versus placebo (20 events, 327 total, 6.1%) for eight RCTs; RR 1.40 [95% CI: 0.87, 2.26] I² = 0%, z = 1.39 (p = 0.16). The number needed to treat with PO to prevent one patient from having persistent symptoms was three for global symptoms and four for abdominal pain. Conclusions In the most comprehensive meta-analysis to date, PO was shown to be a safe and effective therapy for pain and global symptoms in adults with IBS. Electronic supplementary material The online version of this article (10.1186/s12906-018-2409-0) contains supplementary material, which is available to authorized users.
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