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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EIn the IBREST trial, when compared with placebo, a novel targeted delivery system of peppermint oil is more effective in treating symptoms of nonconstipated irritable bowel syndrome at 4 weeks. The trial shows significant improvement in the Total IBS Symptoms Score and 4 of 8 symptom domains. Furthermore, the treatment appears safe and well tolerated.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eirritable bowel syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIBS\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epeppermint oil\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Etargeted release\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIBREST\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egastroenterology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EPeppermint oil has been considered a remedy for bothersome gastrointestinal symptoms for centuries. While a recent meta-analysis suggested that peppermint oil was a safe and effective short-term treatment of irritable bowel syndrome (IBS) [Khanna R et al. \u003Cem\u003EJ Clin Gastroenterol\u003C\/em\u003E. 2014], oral ingestion of single-unit, liquid-filled enteric-coated peppermint oil can be associated with adverse effects such as heartburn, dyspepsia, or anal burning. These adverse effects likely occur due to the unpredictability of peppermint oil release in the gastrointestinal tract with these older formulations. [Epstein MS et al. DDW 2015 (poster 314)].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA novel, targeted-release formulation of peppermint oil appeared to significantly reduce 4 self-reported symptoms of severe abdominal symptoms associated with IBS, according to research presented in a poster by Brooks D. Cash, MD, University of South Alabama, Mobile, Alabama, USA.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe IBREST trial was a randomized, placebo-controlled, double-blinded study to compare the safety and efficacy of a proprietary, targeted-release formulation of peppermint oil compared with an identical placebo in a US population. This formulation consists of ultra-purified, solid-state microspheres triple-coated to facilitate oral ingestion and rapid delivery of the peppermint oil directly to the small intestine.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EInclusion criteria were the Rome III criteria for IBS with mixed symptoms or diarrhea, Total IBS Symptom Score (TISS) \u0026gt;\u20052 on a scale of 0 to 4, and persistent levels of abdominal pain \u2265\u20054 on a scale of 0 to 10. Patients were excluded if they had any other type of IBS, if they had organic gastrointestinal disease, or if they were unwilling to stop any restricted medications prior to enrolling in the study.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThree weeks before enrollment, patients were required to undergo laboratory testing and washout of all prohibited medicines; rescue medications were not allowed. Patients were also instructed to keep a 2-week baseline system diary. Patients were then randomized to either 2 capsules (each containing 90 mg) of peppermint oil TID (treatment group; n\u2005=\u200535) or to 2 identical placebo capsules TID (placebo; n\u2005=\u200537). The majority of patients were white and were women, with a mean age of 40.7 years (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16785\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16785\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16785\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EPatient Characteristics\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EThe primary outcomes were self-reported differences after 4 weeks of therapy between the 2 groups on the TISS and the frequency and intensity of the 8 symptoms that customarily constitute IBS: abdominal discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain on evacuation, and gas or mucus.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EAt baseline, there was no significant difference between the placebo and treatment groups with regard to the TISS or any of its 8 individual components. At week 4, patients in the treatment group achieved a significant reduction in the TISS (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.0246), as well as in 4 of the 8 individual components\u2014abdominal discomfort, abdominal bloating, pain at evacuation, and urgency of bowel movement (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.05, \u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16786\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16786\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16786\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \u003Cp id=\u0022p-13\u0022 class=\u0022first-child\u0022\u003EPercent Reduction From Baseline in Individual Irritable Bowel Syndrome Symptoms at 4 Weeks\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-16\u0022\u003EThere were 6 treatment-emergent adverse events (TEAEs): 2 in the treatment group and 4 in the placebo group. One TEAE above grade 1 was reported, and no serious TEAEs or deaths were reported. No patients dropped out of the study because of a TEAE.\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003EIn conclusion, patients with nonconstipated IBS randomized to a novel formulation of peppermint oil designed to release in the small intestine showed improvement in the TISS, a global IBS symptom score, as well as many of the common individual IBS symptoms, after 4 weeks of therapy compared with placebo. This formulation of peppermint oil was well tolerated and no safety signals were noted.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/14\/17.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlhj1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzlhj1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}