Official journal of the American College of Gastroenterology

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Gastroenterology" /><meta name="wkhealth_issue" content="11" /><meta name="wkhealth_article_publication_date" content="June 25, 2024" /><meta name="wkhealth_volume" content="119" /><meta name="wkhealth_ovid_accession_number" content="00000434-202411000-00029" /><meta name="wkhealth_issn" content="0002-9270" /><meta name="wkhealth_title" content="No Effect of Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial" /><meta name="wkhealth_authors" content="Knoph, Cecilie Siggaard;Cook, Mathias Ellgaard;Novovic, Srdan;Hansen, Mark Berner;Mortensen, Michael Bau;Nielsen, Liv Bjerre Juul;Høgsberg, Irene Maria;Salomon, Celina;Neergaard, Celine Emilie Lindqvist;Aajwad, Aseel Jabbar;Pandanaboyana, Sanjay;Sørensen, Lone Schmidt;Thorlacius-Ussing, Ole;Frøkjær, Jens Brøndum;Olesen, Søren Schou;Drewes, Asbjørn Mohr" /><meta name="wkhealth_doi" content="10.14309/ajg.0000000000002904" /><meta name="wkhealth_abstract_html_url" content="https://journals.lww.com/ajg/abstract/2024/11000/no_effect_of_methylnaltrexone_on_acute.29.aspx" /><meta name="wkhealth_fulltext_html_url" content="https://journals.lww.com/ajg/fulltext/2024/11000/no_effect_of_methylnaltrexone_on_acute.29.aspx" /><meta name="wkhealth_toc_section" content="ARTICLE" /><meta name="wkhealth_toc_sub_section" content="PANCREAS" /><meta name="wkhealth_eJpId" content="ajg:2024:11000:00029" /><meta name="wkhealth_firstpage" content="2307" /><meta name="wkhealth_date" content="November 2024" /><meta name="wkhealth_pdf_url" content="https://journals.lww.com/ajg/_layouts/15/oaks.journals/downloadpdf.aspx?trckng_src_pg=Other&an=00000434-202411000-00029" /><meta name="Description" content="INTRODUCTION: Opioids used to manage severe pain in acute pancreatitis (AP) might exacerbate the " /><meta property="og:site_name" content="LWW" /><meta property="og:type" content="article" /><meta property="og:title" content="No Effect of Methylnaltrexone on Acute Pancreatitis... : Official journal of the American College of Gastroenterology | ACG" /><meta property="og:description" content="THODS: This double-blind, randomized, placebo-controlled trial included adult patients with AP and systemic inflammatory response syndrome at 4 Danish centers. Patients were randomized to receive 5 days of continuous intravenous methylnaltrexone (0.15 mg/kg/d) or placebo added to the standard of care. The primary end point was the Pancreatitis Activity Scoring System score after 48 hours of treatment. Main secondary outcomes included pain scores, opioid use, disease severity, and mortality. RESULTS: In total, 105 patients (54% men) were randomized to methylnaltrexone (n = 51) or placebo (n = 54). After 48 hours, the Pancreatitis Activity Scoring System score was 134.3 points in the methylnaltrexone group and 130.5 points in the placebo group (difference 3.8, 95% confidence interval [CI] −40.1 to 47.6; P = 0.87). At 48 hours, we found no differences between the groups in pain severity (0.0, 95% CI −0.8 to 0.9; P = 0.94), pain interference (−0.3, 95% CI −1.4 to 0.8; P = 0.55), and morphine equivalent doses (6.5 mg, 95% CI −2.1 to 15.2; P = 0.14). Methylnaltrexone also did not affect the risk of severe disease (8%, 95% CI −11 to 28; P = 0.38) and mortality (6%, 95% CI −1 to 12; P = 0.11). The medication was well tolerated. DISCUSSION: Methylnaltrexone treatment did not achieve superiority over placebo for reducing the severity of AP...." /><meta property="og:image" content="https://images.journals.lww.com/ajg/SocialThumb.00000434-202411000-00029.F1.jpeg" /><meta property="og:image:width" content="1362" /><meta property="og:image:height" content="1010" /><meta property="og:url" content="https://journals.lww.com/ajg/fulltext/2024/11000/no_effect_of_methylnaltrexone_on_acute.29.aspx" /><meta property="twitter:card" content="summary" /><meta name="robots" content="index, follow, noarchive" /><meta name="WT.sv" content="ZUSE1PEJPWEB03" /><meta name="Title" content="Official journal of the American College of Gastroenterology | ACG" /><style id="SPThemeHideForms" type="text/css">body {opacity:0 !important}</style>  <link href="https://fonts.googleapis.com/css?family=Arvo:400,400i,700|Fira+Sans:300,300i,400,400i,500,500i,600,600i,700,700i&display=swap" rel="stylesheet" /> <script> // temporary workaround for Bug 316328:[Stage][Registration][Regression 05.04] - Omniture events are not displayed for article viewer page // prevents JS exception in Adobe launch.js caused by situation when wkhealth_institution_type meta tag is present while wkhealth_institution_name tag is not in the page head // see this check in Adobe launch.js: null != document.querySelector("meta[name='wkhealth_institution_name']") ... // TODO: implement proper code fix after release 05.04.00 deployment var wkhealth_institution_type = document.querySelector("meta[name='wkhealth_institution_type']"); var wkhealth_institution_name = document.querySelector("meta[name='wkhealth_institution_name']"); console.warn(wkhealth_institution_type); console.warn(wkhealth_institution_name); if (wkhealth_institution_type && !wkhealth_institution_name) { console.warn('Workaround in release 05.04.00 - removing wkhealth_institution_type meta tag if wkhealth_institution_name is not present'); wkhealth_institution_type.remove(); } </script> 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SIRS, systemic inflammatory response syndrome.","https://images.journals.lww.com/ajg/Rollover.00000434-202411000-00029.F1.jpeg","https://images.journals.lww.com/ajg/Gallery.00000434-202411000-00029.F1.jpeg","https://journals.lww.com/ajg/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=F1&year=2024&issue=11000&article=00029&type=Fulltext","https://images.journals.lww.com/ajg/Original.00000434-202411000-00029.F1.jpeg","/ajg/pages/imagegallery.aspx?year=2024&issue=11000&article=00029", "ajg_2024_11000_00029_F1");images["T1"]=new image("T1","T2","F1","Table 1.","Baseline demographic details and clinical characteristics","https://images.journals.lww.com/ajg/Rollover.00000434-202411000-00029.T1.jpeg","https://images.journals.lww.com/ajg/Gallery.00000434-202411000-00029.T1.jpeg","https://journals.lww.com/ajg/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=T1&year=2024&issue=11000&article=00029&type=Fulltext","https://images.journals.lww.com/ajg/Original.00000434-202411000-00029.T1.jpeg","/ajg/pages/imagegallery.aspx?year=2024&issue=11000&article=00029", "ajg_2024_11000_00029_T1");images["T2"]=new image("T2","F2","T1","Table 2.","Results from the primary intention-to-treat analysis","https://images.journals.lww.com/ajg/Rollover.00000434-202411000-00029.T2.jpeg","https://images.journals.lww.com/ajg/Gallery.00000434-202411000-00029.T2.jpeg","https://journals.lww.com/ajg/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=T2&year=2024&issue=11000&article=00029&type=Fulltext","https://images.journals.lww.com/ajg/Original.00000434-202411000-00029.T2.jpeg","/ajg/pages/imagegallery.aspx?year=2024&issue=11000&article=00029", "ajg_2024_11000_00029_T2");images["F2"]=new image("F2","T3","T2","Figure 2.","PASS scores in the intention-to-treat population. Line graphs show means and 95% CIs (whiskers) of daily PASS scores (<strong xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">a</strong>) and PASS points within the 5 scoring elements (<strong xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">b</strong>). Data are shown for the intention-to-treat population. Missing data were imputed using the multiple imputation approach. The dashed lines separate the end of treatment and follow-up on day 14. CI, confidence interval; MED, morphine equivalent doses; PASS, Pancreatitis Activity Scoring System; SIRS, systemic inflammatory response syndrome.","https://images.journals.lww.com/ajg/Rollover.00000434-202411000-00029.F2.jpeg","https://images.journals.lww.com/ajg/Gallery.00000434-202411000-00029.F2.jpeg","https://journals.lww.com/ajg/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=F2&year=2024&issue=11000&article=00029&type=Fulltext","https://images.journals.lww.com/ajg/Original.00000434-202411000-00029.F2.jpeg","/ajg/pages/imagegallery.aspx?year=2024&issue=11000&article=00029", "ajg_2024_11000_00029_F2");images["T3"]=new image("T3","","F2","Table 3.","Adverse events","https://images.journals.lww.com/ajg/Rollover.00000434-202411000-00029.T3.jpeg","https://images.journals.lww.com/ajg/Gallery.00000434-202411000-00029.T3.jpeg","https://journals.lww.com/ajg/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=T3&year=2024&issue=11000&article=00029&type=Fulltext","https://images.journals.lww.com/ajg/Original.00000434-202411000-00029.T3.jpeg","/ajg/pages/imagegallery.aspx?year=2024&issue=11000&article=00029", "ajg_2024_11000_00029_T3"); 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document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenJournalId').value == '') { document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenJournalId').value = journalId; } if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.show(); } } function alerts_ShowUnSubscribeeTOCPopup_Root(title, journalId, alertType) { var unSubscribeeTocPopup = $find('unSubscribeToAlerts'); var lblUnsubscribeMessage = document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_lblUnsubscribeMessage'); lblUnsubscribeMessage.innerHTML = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeMessage').value = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnSubscribeAlertType').value = alertType; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeJournalId').value = journalId; $('#' + 'ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_pUnsubscribeButtons').show(); if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.show(); } } function alerts_ShowUnSubscribeeTOCPopup_Citation(title, journalId, ovidId) { var unSubscribeeTocPopup = $find('unSubscribeToAlerts'); var lblUnsubscribeMessage = document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_lblUnsubscribeMessage'); lblUnsubscribeMessage.innerHTML = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeMessage').value = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnSubscribeAlertType').value = 'Citation'; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeJournalId').value = journalId; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenOvidId').value = ovidId; $('#' + 'ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_pUnsubscribeButtons').show(); if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.show(); } } function alerts_ShowUnSubscribeeTOCPopup_Topical(title, journalId, topicalCollectionId) { var unSubscribeeTocPopup = $find('unSubscribeToAlerts'); var lblUnsubscribeMessage = document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_lblUnsubscribeMessage'); lblUnsubscribeMessage.innerHTML = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeMessage').value = title; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnSubscribeAlertType').value = 'Topical'; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenUnsubscribeJournalId').value = journalId; document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenTopicalCollectionId').value = topicalCollectionId; $('#' + 'ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_pUnsubscribeButtons').show(); if (document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenJournalId').value == null || document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenJournalId').value == '') { document.getElementById('ctl00_ctl51_Header_UserActionTools_ucUnsubscribeToAlertsUserControl_hiddenJournalId').value = journalId; } if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.show(); } } function alerts_ShowUnSubscribeeTOCSuccessPopup() { var unSubscribeeTocPopup = $find('unSubscribeToAlerts'); if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.show(); } } $('.js-close').on('click', function() { var unSubscribeeTocPopup = $find('unSubscribeToAlerts'); if (unSubscribeeTocPopup != null) { unSubscribeeTocPopup.hide(); } return false; }); </script> <span id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_dummyTargetControl"></span> <input type="hidden" name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$hiddenSubscribeToEtocPopupState" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenSubscribeToEtocPopupState" value="showemail" /> <input type="hidden" name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$hiddenConfirmSubscriptionPageUrl" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenConfirmSubscriptionPageUrl" /> <input type="hidden" name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$hiddenJournalId" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenJournalId" /> <input type="hidden" name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$hiddenSubscriptionType" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenSubscriptionType" /> <div id="divPopupOverLay" class="Popup-Overlay" style="display: none; position: fixed; left: 0; top: 0; z-index: 3800; width: 1920px; height: 4517px;"></div> <div id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pnlSubscribeToEtoc" class="etoc-popup ej-box-modal-drop-shadow" style="display: none;"> <div tabindex="-1" role="dialog" class="wk-modal horizontally-centered small wk-modal-with-overlay wk-modal-small ejp-modal"> <div id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pnlMain" onkeypress="javascript:return WebForm_FireDefaultButton(event, 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class="wk-field-body"> <input name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$txtEmailAddress" type="text" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_txtEmailAddress" class="ej-box-modal-style-1-input" /> </div> </div> <div class="wk-button-bar"> <div class="wk-button-group-left"> <input type="submit" name="ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$btnContinue" value="Continue" onclick="javascript:WebForm_DoPostBackWithOptions(new WebForm_PostBackOptions("ctl00$ctl51$Header$UserActionTools$SubscribeToEtocPopupControl$btnContinue", "", true, "", "", false, false))" id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_btnContinue" class="primary-button" /> <input type="button" value="Cancel" id="btnCancel" class="js-close secondary-button" /> </div> </div> </div> <div class="wk-field-item"> <div class="wk-field-body"> <a id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hypPrivacy" href="https://journals.lww.com/ajg/_layouts/oaks.journals/privacy.aspx" target="_blank">Privacy Policy</a> </div> </div> </div> </section> </div> <div id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pnlAuthenticatedUser" style="display: none;"> <section class="wk-modal-content"> <header class="wk-modal-header ejp-modal-header"> <div class="wk-modal-title ejp-modal-title"></div> <button aria-label="close dialog" class="js-close primary-button wk-button-icon wk-modal-close ejp-modal-close "><i class="fa fa-times"></i></button> </header> <div class="wk-modal-body"> <div class="wk-field-item"> <p> <strong> <span id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_lblAuthenticatedUserTitle"></span> </strong> </p> </div> <p id="ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pAuthenticatedUserMessage"> </p> </div> </section> </div> </div> </div> <div id="ej-clear-float"> </div> <script type="text/javascript"> function alerts_SaveSubscriptionTypeInHiddenField(url, subscriptionType, journalId, yearId, issueId, articleId) { if (journalId && yearId && issueId && articleId) { logCounterDataAlertWhenCitedSynchronously(journalId, yearId, issueId, articleId); } $('#' + 'ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenSubscriptionType').val(subscriptionType); $('#' + 'ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenJournalId').val(journalId); if (url) window.location = url; else __doPostBack('hypSubscribeToAlerts'); return false; } function alerts_ShowSubscribeeTOCPopup(journalTitle, journalId, subscriptionType, displaySubscriptionType) { $('#' + 'ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenSubscriptionType').val(subscriptionType); var subscribeToEtocPopup = $find('subscribeToEtoc'); subscribeToEtocPopup.show(); document.getElementsByTagName( 'html' )[0].classList.add('no-scroll'); var modelPopupState = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenSubscribeToEtocPopupState'); var emailTextBox = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_txtEmailAddress'); var thanksPanel = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pnlAuthenticatedUser'); var mainPanel = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_pnlMain'); var thankYouMessageUnAuthenticated = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_lblThankYouMessage'); var thankYouMessageAuthenticated = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_lblAuthenticatedUserTitle'); if (!displaySubscriptionType) { displaySubscriptionType = subscriptionType; } if (modelPopupState.value == 'showthanksmessage') { thanksPanel.style.display = "block"; mainPanel.style.display = "none"; thankYouMessageAuthenticated.innerHTML = "Thank you for subscribing to the " + displaySubscriptionType + " for " + journalTitle + "."; } if (modelPopupState.value == 'showemail') { thanksPanel.style.display = "none"; mainPanel.style.display = "block"; thankYouMessageUnAuthenticated.innerHTML = "Thank you for choosing to subscribe to the " + displaySubscriptionType + " for " + journalTitle + "."; } if ($('.etoc-popup') != null) { document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenJournalId').value = journalId; if (modelPopupState.value == 'showemail') emailTextBox.focus(); } } $('.js-close').on('click', function () { document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_txtEmailAddress').value = ""; document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_cvEmailError').style.display = "none"; var pageUrl = document.getElementById('ctl00_ctl51_Header_UserActionTools_SubscribeToEtocPopupControl_hiddenConfirmSubscriptionPageUrl'); var subscribeeTocPopup = $find('subscribeToEtoc'); if (subscribeeTocPopup != null) { subscribeeTocPopup.hide(); document.getElementsByTagName( 'html' )[0].classList.remove('no-scroll'); if (pageUrl.value !== '' && pageUrl.value !== window.location.pathname) window.location = pageUrl.value; } return false; }); </script> <div id="ctl00_ctl51_Header_UserActionTools_eTocTopContainer"> <div id="eTocTop" style="display: none;"> <a rel="nofollow" title href="javascript:javascript: alerts_ShowSubscribeeTOCPopup('Official journal of the American College of Gastroenterology | ACG','ajg','eTOC', 'eTOC');;" onclick="javascript: alerts_ShowSubscribeeTOCPopup('Official journal of the American College of Gastroenterology | ACG','ajg','eTOC', 'eTOC');"><span id="ctl00_ctl51_Header_UserActionTools_alertLinkControlTop_defaultText" class="hideOnFixed">Subscribe to eTOC</span></a> 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value="disableButton" /> </div> </div> <script> $(function() { try { var objSearchBox = { btnGlobalSearchMagnifierId: 'ctl00_ctl51_Header_SearchTopBoxControl_btnGlobalSearchMagnifier', searchButtonId: 'ctl00_ctl51_Header_SearchTopBoxControl_btnGlobalSearch', txtKeywordsId: 'ctl00_ctl51_Header_SearchTopBoxControl_txtKeywords', hfldKeywordsHiddenId: 'ctl00_ctl51_Header_SearchTopBoxControl_hfldKeywords', defaultSearchText: 'Search' }; new Searchbox(objSearchBox).Init(); } catch (e) { console.error(e); } }); //autocomplete functionality for basic search //this functionality will call the SBA url and start suggesting after typing 3rd character var textKeywords = null; var hiddenAutocompleteApiUrl = null; var buttonGlobalSearch = null; $(function () { try { var objAutocomplete = { hiddenIsAutoCompleteEnabled: $('#ctl00_ctl51_Header_SearchTopBoxControl_IsAutoCompleteEnabled'), textKeywords: $('#ctl00_ctl51_Header_SearchTopBoxControl_txtKeywords'), hiddenAutocompleteApiUrl: 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data-config="{"browsingHistory":{"isEnabled":true,"serviceUrl":"https://apim-hlrp-ejp-prod.azure-api.net/ee","pdfDownloadUrl":"/_layouts/15/oaks.journals/downloadpdf.aspx?trckng_src_pg=HistoryTab"}}"></div> <div id="zz1_TopNavigationMenu" class="navbar-collapse collapse js-top-navigation-menu noindex ms-core-listMenu-horizontalBox"> <ul id="zz2_RootAspMenu" class="root ms-core-listMenu-root static"> <li class="static dynamic-children"><span class="static dynamic-children menu-item ms-core-listMenu-item ms-displayInline ms-navedit-linkNode"><span aria-haspopup="true" class="additional-background ms-navedit-flyoutArrow dynamic-children"><span class="menu-item-text">Articles & Issues</span></span></span><ul aria-hidden="true" class="dynamic"> <li class="dynamic"><a class="dynamic menu-item ms-core-listMenu-item ms-displayInline ms-navedit-linkNode" href="/ajg/pages/currenttoc.aspx" accesskey="1"><span class="additional-background ms-navedit-flyoutArrow"><span 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Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial', '06252024', 'Cecilie Siggaard Knoph, Mathias Ellgaard Cook, Srdan Novovic, et al', '119', '11', 'Copyright \u00A9 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology', '00000434-202411000-00029', '', true, 'CCBY-NC-ND'); } </script> <div id="ArticleContainer"> <article id="ej-article-view" class="js-article-view ej-article-view" xmlns:ssr="http://ssr-eus-go-csi.cloudapp.net/v1/assets" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xhtml="http://www.w3.org/1999/xhtml"><section class="ejp-r-article-subsection"><div class="ejp-r-article-subsection__text">ARTICLE: PANCREAS</div></section><header class="ejp-article-header"><h1 class="ejp-article-title">No Effect of Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial</h1></header><section id="ejp-article-authors"><p id="P7"><i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Knoph, Cecilie Siggaard MD', 'https://orcid.org/0000-0002-8373-1487');" onmouseover="javascript:ToolTip_Orcid('Knoph, Cecilie Siggaard MD', 'https://orcid.org/0000-0002-8373-1487');"></i>Knoph, Cecilie Siggaard MD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">1,2</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Cook, Mathias Ellgaard MSc', 'https://orcid.org/0000-0002-4157-1091');" onmouseover="javascript:ToolTip_Orcid('Cook, Mathias Ellgaard MSc', 'https://orcid.org/0000-0002-4157-1091');"></i>Cook, Mathias Ellgaard MSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">1,2</sup>; Novovic, Srdan MD, PhD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">3,4</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Hansen, Mark Berner MD, DMSc', 'https://orcid.org/0000-0003-1305-3382');" onmouseover="javascript:ToolTip_Orcid('Hansen, Mark Berner MD, DMSc', 'https://orcid.org/0000-0003-1305-3382');"></i>Hansen, Mark Berner MD, DMSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">5</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Mortensen, Michael Bau MD, DMSc', 'https://orcid.org/0000-0002-7270-5005');" onmouseover="javascript:ToolTip_Orcid('Mortensen, Michael Bau MD, DMSc', 'https://orcid.org/0000-0002-7270-5005');"></i>Mortensen, Michael Bau MD, DMSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">6</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Nielsen, Liv Bjerre Juul MD', 'https://orcid.org/0000-0002-2255-6507');" onmouseover="javascript:ToolTip_Orcid('Nielsen, Liv Bjerre Juul MD', 'https://orcid.org/0000-0002-2255-6507');"></i>Nielsen, Liv Bjerre Juul MD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">5</sup>; Høgsberg, Irene Maria MD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">6</sup>; Salomon, Celina MSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">7</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Neergaard, Celine Emilie Lindqvist MD', 'https://orcid.org/0009-0000-3015-7920');" onmouseover="javascript:ToolTip_Orcid('Neergaard, Celine Emilie Lindqvist MD', 'https://orcid.org/0009-0000-3015-7920');"></i>Neergaard, Celine Emilie Lindqvist MD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">6</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Aajwad, Aseel Jabbar MD', 'https://orcid.org/0009-0006-0842-2402');" onmouseover="javascript:ToolTip_Orcid('Aajwad, Aseel Jabbar MD', 'https://orcid.org/0009-0006-0842-2402');"></i>Aajwad, Aseel Jabbar MD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">7</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Pandanaboyana, Sanjay FRCS', 'https://orcid.org/0000-0003-3099-2197');" onmouseover="javascript:ToolTip_Orcid('Pandanaboyana, Sanjay FRCS', 'https://orcid.org/0000-0003-3099-2197');"></i>Pandanaboyana, Sanjay FRCS<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">8</sup>; Sørensen, Lone Schmidt MD, PhD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">9</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Thorlacius-Ussing, Ole MD, DMSc', 'https://orcid.org/0000-0003-4963-1551');" onmouseover="javascript:ToolTip_Orcid('Thorlacius-Ussing, Ole MD, DMSc', 'https://orcid.org/0000-0003-4963-1551');"></i>Thorlacius-Ussing, Ole MD, DMSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">9</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Frøkjær, Jens Brøndum MD, DMSc', 'https://orcid.org/0000-0001-8722-0070');" onmouseover="javascript:ToolTip_Orcid('Frøkjær, Jens Brøndum MD, DMSc', 'https://orcid.org/0000-0001-8722-0070');"></i>Frøkjær, Jens Brøndum MD, DMSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">10,2</sup>; <i class="wki icon-orcid" onclick="javascript:ToolTip_Orcid('Olesen, Søren Schou MD, PhD', 'https://orcid.org/0000-0003-3916-3168');" onmouseover="javascript:ToolTip_Orcid('Olesen, Søren Schou MD, PhD', 'https://orcid.org/0000-0003-3916-3168');"></i>Olesen, Søren Schou MD, PhD<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">1,2</sup>; Drewes, Asbjørn Mohr MD, PhD, DMSc<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">1,2</sup></p><section><a href="#" id="ejp-article-authors-link"> Author Information <i class="wk-icon-arrow-down-r"></i></a></section></section><section id="ejp-article-authors-info" class="ejp-article-authors-info ejp-article-authors-info--hidden"><div class="ejp-article-authors-info-holder"> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">1</sup>Mech-Sense and Centre for Pancreatic Diseases, Department of Gastroenterology & Hepatology, Aalborg University Hospital, Aalborg, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">2</sup>Department of Clinical Medicine, Aalborg University, Aalborg, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">3</sup>Pancreatitis Centre East, Gastro Unit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">4</sup>Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">5</sup>Digestive Disease Centre K, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">6</sup>Odense Pancreas Centre, HPB Section, Department of Surgery, Odense University Hospital, Odense, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">7</sup>Department of Surgery A4, Odense University Hospital, Svendborg, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">8</sup>HPB and Transplant Unit, Freeman Hospital, Newcastle upon Tyne, UK;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">9</sup>Department of Gastrointestinal Surgery A, Aalborg Hospital, Aalborg, Denmark;</p> <p id=""><sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">10</sup>Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.</p> <p id="cor1"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Correspondence:</strong> Asbjørn Mohr Drewes, MD, PhD, DMSc. E-mail: <span><a href="/cdn-cgi/l/email-protection#bdd0dcd4d1c9d287dcd0d9fdcfd393d9d6" onclick="javascript:window.open('mailto:mailto:amd@rn.dk');return false"><span class="__cf_email__" data-cfemail="94f5f9f0d4e6fabaf0ff">[email protected]</span></a></span>.</p> <p id=""><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">SUPPLEMENTARY MATERIAL</strong> accompanies this paper at <span><a href="https://links.lww.com/AJG/D316" onclick="javascript:window.open('https://links.lww.com/AJG/D316');return false">https://links.lww.com/AJG/D316</a></span></p> <p id="">This is an open access article distributed under the terms of the <span><a href="http://creativecommons.org/licenses/by-nc-nd/4.0/" onclick="javascript:window.open('http://creativecommons.org/licenses/by-nc-nd/4.0/');return false">Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND)</a></span>, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.</p> </div></section><section id="article-journal-info"><div class="ej-journal-info"><span class="ej-journal-name">The American Journal of Gastroenterology </span><span id="ej-journal-date-volume-issue-pg"><a href="/ajg/pages/currenttoc.aspx">119(11):p 2307-2316, November 2024.</a></span><span> | </span><span class="ej-journal-doi">DOI: </span>10.14309/ajg.0000000000002904<a id="ej-article-indicators-ccl" onmouseover="javascript:Tooltip_CCL('This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.')" onmouseout="javascript:Tooltip_MouseOut()" href="http://creativecommons.org/licenses/by-nc-nd/4.0/" target="_blank"><span class="ejp-article-indicators__ccl"></span></a></div></section><section id="ejp-article-indicators" class="ejp-article-indicators"><ul class="ejp-article-indicators__list"> <li id="ej-article-indicators-open" class="ejp-article-indicators__list-item" onmouseover="javascript:Tooltip_Open()" onmouseout="javascript:Tooltip_MouseOut()"><span class="ejp-indicator">Open</span></li> <li id="ej-article-indicators-sam" class="ejp-article-indicators__list-item" onmouseover="javascript:Tooltip_SDC()" onmouseout="javascript:Tooltip_MouseOut()"><a class="ejp-indicator" href="#ej-article-sam-container">SDC</a></li> <li id="ej-article-indicators-imageabstract" class="ejp-article-indicators__list-item" onmouseover="javascript:Tooltip_ImageAbstract()" onmouseout="javascript:Tooltip_MouseOut()"><span class="ejp-indicator">Infographic</span></li> </ul><button id="openArticleMetricsPopupButton" type="button" class="wk-button wk-button-ghost wk-button-icon-left ejp-article-metrics-btn" data-articleMetricsEndpoint="//services.journals.lww.com/IntegrationServices/ArticleMetricsService.svc" data-articleMetricsDetailsUrl="https://wolterskluwer.altmetric.com/details/" data-doi="10.14309/ajg.0000000000002904" data-suiteId="vrs_woltere_journalsglobalvrs" data-articlePublicationDate="2024-06-25" data-articlePublicationDateString="June 25, 2024" data-receivedDate="2024-02-28" data-revisionReceivedDate="" data-acceptedDate="2024-06-06" data-crossrefRefLinkRoot="https://doi.org/" data-medlineRefLinkRoot="http://www.ncbi.nlm.nih.gov/pubmed/" data-pubMedId="38916223"><i class="wk-icon-filled-chart-r"></i><i class="wk-icon-filled-chart-white-r"></i> Metrics </button></section><section class="ejp-article-tabs" id="abstractWrap"><h2 class="ejp-article-tabs-heading">Abstract</h2> <div class="ejp-article-tabs__tabpanel" id="panel1" role="tabpanel" aria-labelledby="tab1"> <div id="article-abstract-content1"> <div class="ejp-article-text-abstract"> <h3>INTRODUCTION: </h3> <p>Opioids used to manage severe pain in acute pancreatitis (AP) might exacerbate the disease through effects on gastrointestinal and immune functions. Methylnaltrexone, a peripherally acting µ-opioid receptor antagonist, may counteract these effects without changing analgesia.</p> <h3>METHODS: </h3> <p>This double-blind, randomized, placebo-controlled trial included adult patients with AP and systemic inflammatory response syndrome at 4 Danish centers. Patients were randomized to receive 5 days of continuous intravenous methylnaltrexone (0.15 mg/kg/d) or placebo added to the standard of care. The primary end point was the Pancreatitis Activity Scoring System score after 48 hours of treatment. Main secondary outcomes included pain scores, opioid use, disease severity, and mortality.</p> <h3>RESULTS: </h3> <p>In total, 105 patients (54% men) were randomized to methylnaltrexone (n = 51) or placebo (n = 54). After 48 hours, the Pancreatitis Activity Scoring System score was 134.3 points in the methylnaltrexone group and 130.5 points in the placebo group (difference 3.8, 95% confidence interval [CI] −40.1 to 47.6; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.87). At 48 hours, we found no differences between the groups in pain severity (0.0, 95% CI −0.8 to 0.9; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.94), pain interference (−0.3, 95% CI −1.4 to 0.8; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.55), and morphine equivalent doses (6.5 mg, 95% CI −2.1 to 15.2; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.14). Methylnaltrexone also did not affect the risk of severe disease (8%, 95% CI −11 to 28; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.38) and mortality (6%, 95% CI −1 to 12; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.11). The medication was well tolerated.</p> <h3>DISCUSSION: </h3> <p>Methylnaltrexone treatment did not achieve superiority over placebo for reducing the severity of AP.</p> </div> <div class="ejp-article-graphical-abstract" id=""> <div class="ejp-article-graphical-abstract-container"> <p id="JCL-P-5"><section class="ejp-r-article-images"><figure class="ejp-r-article-images__figure"><a href="/_layouts/oaks.journals/ImageView.aspx?k=ajg:2024:11000:00029&i=ga&year=2024&issue=11000&article=00029" target="_blank" class="ejp-r-article-images__image-link"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/GAPreview.00000434-202411000-00029.ga.jpeg" data-srcset="https://images.journals.lww.com/ajg/GAPreview@2.00000434-202411000-00029.ga.jpeg 2x" srcset="" alt="Abstract"></a></figure></section><a class="ejp-article-graphical-abstract__export-link" href="/_layouts/OAKS.Journals/ImageInfoService.svc/GetImagePptx/ajg/2024/11000/00029/ga" aria-label="Download image graphical abstract as ppt"><i class="icon-powerpoint"></i> Export </a></p> </div> </div> </div> </div></section><div class="ejp-fulltext-content js-ejp-fulltext-content"><section id="ArticleBody"><h2 class="ejp-article-outline-heading" data-level="1" id="s1">INTRODUCTION</h2> <p id="JCL-P-6">Acute pancreatitis (AP) has an increasing global incidence, resulting in substantial morbidity and, in severe cases, even mortality (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R1 R2">1,2</a></sup>). Nevertheless, no targeted pharmacotherapy has been identified for this disease (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R3">3</a></sup>). Patients with AP suffer from severe epigastric pain, often warranting opioid treatment (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R1 R4 R5">1,4,5</a></sup>). Furthermore, there is preclinical evidence suggesting increased levels of endogenous opioids in patients with AP (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R6">6</a></sup>).</p> <p id="JCL-P-7">Opioids (endogenous or exogenous) exert their peripheral effects by binding to the µ-receptors in the enteric nervous system (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R7">7</a></sup>). Human studies found decreased gastrointestinal secretion and dysmotility during opioid treatment (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R8 R9">8,9</a></sup>). The latter may result in intestinal bacterial overgrowth, which, together with an impaired intestinal permeability (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R10 R11">10,11</a></sup>), may contribute to the frequent presence of enteric-derived bacteria in infected pancreatic necrosis and Gram-negative sepsis in patients with AP (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R12">12</a></sup>). Finally, opioids can cause spasms of the sphincter of Oddi and reduce fluid secretion (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R8">8</a></sup>), which may reduce the flow within the pancreatic duct system, worsen pancreatic autodigestion, and prevent the resolution of intrapancreatic inflammation.</p> <p id="JCL-P-8">Methylnaltrexone, a peripherally acting µ-opioid receptor antagonist with limited capacity to cross the blood-brain barrier, is indicated for opioid-induced constipation and has the potential to counteract the peripheral effects of opioids without affecting analgesia (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R13 R14">13,14</a></sup>). We hypothesized that treatment with methylnaltrexone would restrict putative adverse effects of endogenous and exogenous opioids and reduce disease severity in patients with predicted moderately severe or severe AP. We aimed to examine the clinical efficacy, tolerability, and safety of methylnaltrexone compared with placebo through assessments of (i) disease severity as measured by the Pancreatitis Activity Scoring System (PASS) score, (ii) symptoms as measured by validated questionnaires, and (iii) clinical outcomes such as length of admission, the severity of AP according to the revised Atlanta Classification (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R5">5</a></sup>), and mortality.</p> <h2 class="ejp-article-outline-heading" data-level="1" id="s2">METHODS</h2> <h3 class="ejp-article-outline-heading" data-level="2" id="s2-1">Study design and participants</h3> <p id="JCL-P-9">This multicenter, double-blind, randomized, placebo-controlled, investigator-initiated, superiority trial was conducted at 4 Danish pancreas referral centers (Aalborg University Hospital, Aalborg; Odense University Hospital, Svendborg; and Copenhagen University Hospitals, Hvidovre and Bispebjerg). The previously published trial protocol (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R15">15</a></sup>) adhered to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R16">16</a></sup>). The protocol is available online at <span><a href="http://ClinicalTrials.gov" onclick="javascript:window.open('http://ClinicalTrials.gov');return false">ClinicalTrials.gov</a></span> (Identifier: NCT04743570), where the study was registered before the inclusion of subjects. The study was approved by the North Denmark Region Committee on Health Research Ethics (Identifier: N-20200060) and the Danish Medicines Agency (EudraCT identifier: 2020-002313-18) and followed the principles of the Helsinki Declaration. All 4 recruiting centers were regularly inspected by an independent monitor appointed by the Good Clinical Practice unit at the respective sites. We screened all adult patients between 18 and 85 years admitted with AP according to the Atlanta criteria (2 of the following: severe, epigastric pain; serum amylase or lipase 3 times the upper normal limit; and characteristic AP imaging findings) (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R5">5</a></sup>). Patients fulfilling 2 or more systemic inflammatory response syndrome (SIRS) criteria within the past 24 hours were eligible for inclusion. The SIRS criteria were assessed based on body temperature (<36 °C or >38 °C), white blood cell count (<4,000 cells/mm<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">3</sup> or >12,000 cells/mm<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">3</sup>), respiration (frequency >20/min or PaCO<sub xmlns:mrws="http://webservices.ovid.com/mrws/1.0">2</sub> <32 mm Hg), and pulse (>90 beats per minute). Until December 2021, we excluded patients with symptoms for more than 48 hours, but this criterion was omitted due to the lack of scientific rationale for the 48-hour cutoff and stagnant enrollment. We excluded patients with an allergy to methylnaltrexone, major obstruction or perforation of the intestines, abdominal cancer, need for dialysis, severe liver cirrhosis (Child-Pugh class B or C), and pregnancy or current lactation (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R14">14</a></sup>). Furthermore, we excluded patients with definite chronic pancreatitis (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R17">17</a></sup>), preexisting renal insufficiency (habitual estimated glomerular filtration rate below 45 mL/min/1.73 m<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">2</sup>), severe preexisting comorbidities, and severe nonpancreaticobiliary infections (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R15">15</a></sup>). All patients gave written informed consent.</p> <h3 class="ejp-article-outline-heading" data-level="2" id="s2-2">Intervention</h3> <p id="JCL-P-10">Patients were randomized (1:1) to receive a daily amount of either 0.15 mg/kg methylnaltrexone or a corresponding volume of placebo (lactated Ringer). This dosage aligned with the approved subcutaneous use of methylnaltrexone for opioid-induced constipation (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R14">14</a></sup>) and previous intravenous use for research purposes (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R18">18</a></sup>). The daily dose of methylnaltrexone or placebo was mixed in 1,000 mL of lactated Ringer and delivered by continuous intravenous infusion over 24 hours, which was repeated daily for a maximum of 5 days. Daily doses were reduced by 50% for severe renal impairment (estimated glomerular filtration rate <30 mL/min) during study participation, but otherwise, the daily doses were fixed based on admission weight. The infusion of methylnaltrexone or placebo was discontinued if the patient required dialysis, was discharged, put on medical leave, or transferred to another hospital. Medication compliance was monitored using the administrated volume of study medication and the weight of used vials. Randomization was conducted using random block sizes without stratification by The Hospital Pharmacy at Herlev Hospital. They were responsible for all procedures related to randomization, including generating the random allocation sequence and distributing the study medications. Study medication was packaged and labeled into vials with methylnaltrexone and placebo, having a similar appearance. Patients, study personnel, and treatment-responsible medical personnel were blinded to the allocation. During study participation, patients received unrestricted treatment according to the standard of care, following international guidelines (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R19">19</a></sup>). This included fluid resuscitation, analgesics (opioid and nonopioid), laxative treatment, nutrition, antibiotics, and surgical interventions, such as endoscopic retrograde cholangiopancreatography and prophylactic cholecystectomy, as prescribed by the treatment-responsible physicians.</p> <h3 class="ejp-article-outline-heading" data-level="2" id="s2-3">Outcomes</h3> <p id="JCL-P-11">The primary outcome was the PASS score after 48 hours of treatment. We choose 48 hours as the primary assessment time point since methylnaltrexone rapidly reaches a steady state with both subcutaneous and intravenous use (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R20 R21">20,21</a></sup>), and at this minimum time frame, AP severity can be determined (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R5">5</a></sup>). The PASS score was selected for its robustness, extensive validation in AP, and simple calculation using clinical variables available from routine management (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R22 R23">22,23</a></sup>). The PASS score was recorded daily based on the following parameters: the presence of organ failure (100 points per system), the number of SIRS criteria fulfilled (25 points per criterion), the maximum intensity of abdominal pain (5 points per numeric rating scale point ranging from 0 to 10), tolerance to solid diet (40 points if solid diet was not tolerated, 0 points if solid diet was tolerated), and morphine equivalent doses (5 points per intravenous morphine equivalent dose) (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R24">24</a></sup>). Since we studied the temporal evolution of the PASS score, we found it appropriate to select patients based on SIRS at baseline despite the SIRS being included in the PASS score. We used the Modified Marshall Scoring System to assess organ failure. For the evaluation of respiratory failure, we used peripheral capillary oxygen saturation measures when arterial blood oxygen levels were unavailable (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R25 R26">25,26</a></sup>). All types of opioids administered were registered and subsequently converted to morphine-equivalent doses (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R27">27</a></sup>). Prespecified secondary outcomes were the AP severity (revised Atlanta Classification) (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R5">5</a></sup>); quantification of need for analgesics, intravenous fluids, or antibiotics; length of admission; and mortality at 30 and 90 days. Patients were asked to complete 3 validated questionnaires daily during treatment: The modified Brief Pain Inventory short form (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R28">28</a></sup>), the Bristol Stool Form Scale (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R29">29</a></sup>), and the Gastrointestinal Symptom Rating Scale (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R30">30</a></sup>). As the interference score of the Brief Pain Inventory questionnaire is irrelevant in an acute setting, we chose not to report this in the primary analysis. We also registered biochemistry (C-reactive protein, white blood cell count, creatinine, amylase, albumin) and the need for laxatives daily during treatment. A modified PASS score excluding the morphine equivalent doses module was included post hoc as a secondary outcome due to variability in opioid use (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R31">31</a></sup>). At the follow-up visit on day 14, we registered the PASS score, questionnaires, biochemistry, and quantification of analgesics, intravenous fluids, laxatives, and antibiotics. For safety evaluation, adverse events and serious adverse events were registered.</p> <h3 class="ejp-article-outline-heading" data-level="2" id="s2-4">Statistical analysis</h3> <p id="JCL-P-12">The trial was powered to detect a 25-point difference in PASS scores between groups after 48 hours of treatment, which was previously indicated to separate mild and severe AP (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R23 R32">23,32</a></sup>). Based on previous research on the PASS score, we assumed a within-group SD of 40 points (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R23 R32">23,32</a></sup>). With 80% power, and a 2-sided α level of 0.05, the power calculation required 41 patients per group, and the prespecified sample size was 90 patients. Descriptive statistics for continuous variables were expressed as mean ± SD or median (interquartile range [IQR]) depending on normality, which was assessed by the Shapiro-Wilk test. Categorical data were presented as numbers and proportions. The primary analysis was by intention-to-treat and involved data collected within the treatment period of all patients who underwent randomization (numbers at risk, <a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('F2', '00000434-202411000-00029');">Figure 2</a>). Variables with missing data underwent multiple imputation before analysis. For the primary outcome, differences between treatment groups were tested using a robust linear mixed model of repeated measures. We included terms for the assessment time point, treatment group, and interaction between the assessment time points and treatment group. From this model, we extracted point estimates for the mean PASS score, SEM, and the mean difference with a 95% confidence interval (CI) after 48 hours (primary end point). Secondary outcomes that were measured repeatedly were analyzed using a robust linear mixed model as for the primary outcome. Single time point measurements of continuous data were analyzed by the Student <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">t</em> test or Wilcoxon rank-sum test, and the results were presented as the mean difference with 95% CI. Categorical data were analyzed using the χ<sup xmlns:mrws="http://webservices.ovid.com/mrws/1.0">2</sup> test or Fisher exact test as appropriate, and the results were presented as the risk differences with a 95% CI. In addition to the intention-to-treat analysis, we performed an analysis of the per-protocol population (prespecified as ≥75% treatment compliance within the first 48 hours of treatment) and a complete case analysis of the intention-to-treat population. We also performed an intention-to-treat analysis of change-from-baseline data. Multiple imputation was performed using the package “mice” in R studio with predictive mean matching for continuous data and logistic regression for binary outcomes. Statistical significance was defined as a 2-sided <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> value below 0.05. All statistical methods were prespecified in the statistical analysis plan (available online at <span><a href="http://ClinicalTrials.gov" onclick="javascript:window.open('http://ClinicalTrials.gov');return false">ClinicalTrials.gov</a></span>) except for the handling of missing data, including the multiple imputation approach and complete case analysis. Statistical analyses were performed using STATA (version 16.0) and R studio (version 4.3.0, packages: tidyverse, ggplot2, ggpubr, mice, lubridate, and haven).</p> <h2 class="ejp-article-outline-heading" data-level="1" id="s3">RESULTS</h2> <h3 class="ejp-article-outline-heading" data-level="2" id="s3-1">Participant flow</h3> <p id="JCL-P-13">Of 748 patients with AP assessed for eligibility, 105 were randomized between May 14, 2021, and April 9, 2023, as illustrated in <a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('F1', '00000434-202411000-00029');">Figure 1</a>. In total, 51 patients were allocated to methylnaltrexone, and 54 patients were allocated to placebo (intention-to-treat population). The trial concluded with primary end point data from 91 patients, of which 45 patients were in the methylnaltrexone group and 46 patients were in the placebo group. The per-protocol population had 43 patients in the methylnaltrexone group and 46 patients in the placebo group.</p><section class="ejp-r-article-images"><figure class="ejp-r-article-images__figure"><a href="javascript:void(0)" class="ejp-r-article-images__image-link" onclick="showSlideShowByImageID('F1', '00000434-202411000-00029')"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/ArticleViewerPreview.00000434-202411000-00029.F1.jpeg" data-srcset="https://images.journals.lww.com/ajg/ArticleViewerPreview@2.00000434-202411000-00029.F1.jpeg 2x" srcset="" alt="F1"></a><figcaption class="ejp-r-article-images__figcaption"><a href="javascript:void(0)" class="ejp-r-article-images__figcaption-link" onclick="showSlideShowByImageID('F1', '00000434-202411000-00029')">Figure 1.: </a><div class="ejp-r-article-images__figcaption-text">Flowchart for screening, recruitment, randomization, and follow-up in the trial. SIRS, systemic inflammatory response syndrome.</div></figcaption></figure></section><h3 class="ejp-article-outline-heading" data-level="2" id="s3-2">Baseline characteristics</h3> <p id="JCL-P-14">The median age in the intention-to-treat population was 57 (IQR 45–69) years, and 57 patients (54%) were male. Biliary etiology, which occurred in 55 patients (52%), was the most common, followed by alcoholic AP, which was found in 31 patients (30%). The median baseline PASS score was 158 (IQR 114–228) points in the methylnaltrexone group and 138 (IQR 98–218) points in the placebo group. The median time from symptom debut to inclusion was 37 (IQR 22–62) hours in the methylnaltrexone group and 38 (IQR 23–67) hours in the placebo group. Baseline demographic details and clinical characteristics were balanced between groups (<a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('T1', '00000434-202411000-00029');">Table 1</a>).</p><section class="ejp-r-article-images"><figure class="ejp-r-article-images__figure"><a href="javascript:void(0)" class="ejp-r-article-images__image-link" onclick="showSlideShowByImageID('T1', '00000434-202411000-00029')"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/ArticleViewerPreview.00000434-202411000-00029.T1.jpeg" data-srcset="https://images.journals.lww.com/ajg/ArticleViewerPreview@2.00000434-202411000-00029.T1.jpeg 2x" srcset="" alt="T1"></a><figcaption class="ejp-r-article-images__figcaption"><a href="javascript:void(0)" class="ejp-r-article-images__figcaption-link" onclick="showSlideShowByImageID('T1', '00000434-202411000-00029')">Table 1.: </a><div class="ejp-r-article-images__figcaption-text">Baseline demographic details and clinical characteristics</div></figcaption></figure></section><h3 class="ejp-article-outline-heading" data-level="2" id="s3-3">Primary outcome</h3> <p id="JCL-P-15">At 48 hours, the estimated mean PASS score was 134.3 points in the methylnaltrexone group and 130.5 points in the placebo group (difference 3.8 points, 95% CI −40.1 to 47.6; <em xmlns:mrws="http://webservices.ovid.com/mrws/1.0">P</em> = 0.87) (<a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('T2', '00000434-202411000-00029');">Table 2</a> and <a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('F2', '00000434-202411000-00029');">Figure 2a</a>). This similarity between groups seemed balanced across all 5 scoring elements, including organ failure scores (<a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('F2', '00000434-202411000-00029');">Figure 2b</a>).</p><section class="ejp-r-article-images"><figure class="ejp-r-article-images__figure"><a href="javascript:void(0)" class="ejp-r-article-images__image-link" onclick="showSlideShowByImageID('T2', '00000434-202411000-00029')"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/ArticleViewerPreview.00000434-202411000-00029.T2.jpeg" data-srcset="https://images.journals.lww.com/ajg/ArticleViewerPreview@2.00000434-202411000-00029.T2.jpeg 2x" srcset="" alt="T2"></a><figcaption class="ejp-r-article-images__figcaption"><a href="javascript:void(0)" class="ejp-r-article-images__figcaption-link" onclick="showSlideShowByImageID('T2', '00000434-202411000-00029')">Table 2.: </a><div class="ejp-r-article-images__figcaption-text">Results from the primary intention-to-treat analysis</div></figcaption></figure><figure class="ejp-r-article-images__figure"><a href="javascript:void(0)" class="ejp-r-article-images__image-link" onclick="showSlideShowByImageID('F2', '00000434-202411000-00029')"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/ArticleViewerPreview.00000434-202411000-00029.F2.jpeg" data-srcset="https://images.journals.lww.com/ajg/ArticleViewerPreview@2.00000434-202411000-00029.F2.jpeg 2x" srcset="" alt="F2"></a><figcaption class="ejp-r-article-images__figcaption"><a href="javascript:void(0)" class="ejp-r-article-images__figcaption-link" onclick="showSlideShowByImageID('F2', '00000434-202411000-00029')">Figure 2.: </a><div class="ejp-r-article-images__figcaption-text">PASS scores in the intention-to-treat population. Line graphs show means and 95% CIs (whiskers) of daily PASS scores (<strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">a</strong>) and PASS points within the 5 scoring elements (<strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">b</strong>). Data are shown for the intention-to-treat population. Missing data were imputed using the multiple imputation approach. The dashed lines separate the end of treatment and follow-up on day 14. CI, confidence interval; MED, morphine equivalent doses; PASS, Pancreatitis Activity Scoring System; SIRS, systemic inflammatory response syndrome.</div></figcaption></figure></section><h3 class="ejp-article-outline-heading" data-level="2" id="s3-4">Secondary outcomes</h3> <p id="JCL-P-16">Secondary outcomes are reported in <a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('T2', '00000434-202411000-00029');">Table 2</a>. The estimated mean modified PASS score at 48 hours of treatment was 84.4 points in the methylnaltrexone group compared with 96.8 points in the placebo group (difference −12.4 points, 95% CI −46.5 to 21.7). Estimated mean morphine equivalent doses at 48 hours were 20.1 mg in the methylnaltrexone group and 13.6 mg in the placebo group (difference 6.5 mg, 95% CI −2.1 to 15.2). At 48 hours, groups reported similar pain severity (difference 0.0, 95% CI −0.8 to 0.9) and pain interference (difference −0.3, 95% CI −1.4 to 0.8) scores from the modified Brief Pain Inventory short form. In the methylnaltrexone group, 26 patients (51%) received laxative treatment during study participation, while 36 patients (67%) required this in the placebo group (risk difference −15%, 95% CI −34 to 2). The median length of admission was 179 hours in the methylnaltrexone group compared with 202 hours in the placebo group (difference −23 hours, 95% CI −85 to 39). In the methylnaltrexone group, 27 patients (53%) developed moderately severe or severe AP, while this was 24 patients (44%) in the placebo group (risk difference 8%, 95% CI −11 to 28). Mortality was similar between groups at day 30 (risk difference 6%, 95% CI −1 to 12) and day 90 (risk difference 4%, 95% CI −3 to 11). Biochemical parameters, antibiotic use, and gastrointestinal symptoms (assessed using the Bristol Stool Form Scale and the Gastrointestinal Symptom Rating Scale) showed no difference between groups (<a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('T2', '00000434-202411000-00029');">Table 2</a> and in the Supplementary Figures S1–S4, see Supplementary Digital Content 1, <span><a href="https://links.lww.com/AJG/D316" onclick="javascript:window.open('https://links.lww.com/AJG/D316');return false">https://links.lww.com/AJG/D316</a></span>). In the methylnaltrexone group, 5 patients (10%) received no opioid during study participation, whereas this was the case for 4 patients (7%) in the placebo group. The per-protocol and complete-case analyses, along with the intention-to-treat analysis using change-from-baseline data, are presented in Supplementary Tables S1–S3 and Figures S1–S5 (see Supplementary Digital Content 1, <span><a href="https://links.lww.com/AJG/D316" onclick="javascript:window.open('https://links.lww.com/AJG/D316');return false">https://links.lww.com/AJG/D316</a></span>). The results of these analyses were comparable with the primary results of the intention-to-treat population using the multiple imputation approach.</p> <h3 class="ejp-article-outline-heading" data-level="2" id="s3-5">Safety and tolerability</h3> <p id="JCL-P-17">Adverse events were observed in 25 patients (49%) in the methylnaltrexone group and 21 patients (39%) in the placebo group (<a href="javascript:void(0)" onclick="javascript:showSlideShowByImageID('T3', '00000434-202411000-00029');">Table 3</a>). Serious adverse events occurred in 3 patients (6%) with methylnaltrexone and included laparoscopic cholecystectomy, aspiration, and suspected allergy. In the placebo group, serious adverse events occurred in 5 patients (9%) and included sepsis, elevated international normalized ratio, laparoscopic cholecystectomy, pneumonia, and gallbladder perforation. None were deemed related to methylnaltrexone treatment. The most common adverse events were hypokalemia, anemia, and diarrhea.</p><section class="ejp-r-article-images"><figure class="ejp-r-article-images__figure"><a href="javascript:void(0)" class="ejp-r-article-images__image-link" onclick="showSlideShowByImageID('T3', '00000434-202411000-00029')"><img class="ejp-r-article-images__img js-lazy-load lazy-load" src="javascript:void(0);" data-src="https://images.journals.lww.com/ajg/ArticleViewerPreview.00000434-202411000-00029.T3.jpeg" data-srcset="https://images.journals.lww.com/ajg/ArticleViewerPreview@2.00000434-202411000-00029.T3.jpeg 2x" srcset="" alt="T3"></a><figcaption class="ejp-r-article-images__figcaption"><a href="javascript:void(0)" class="ejp-r-article-images__figcaption-link" onclick="showSlideShowByImageID('T3', '00000434-202411000-00029')">Table 3.: </a><div class="ejp-r-article-images__figcaption-text">Adverse events</div></figcaption></figure></section><h2 class="ejp-article-outline-heading" data-level="1" id="s4">DISCUSSION</h2> <p id="JCL-P-18">In this multicenter, randomized, placebo-controlled trial of 105 AP patients with SIRS, continuous intravenous methylnaltrexone did not achieve superiority over placebo for reducing disease severity. Furthermore, the medication did not seem to affect symptoms or outcomes of the disease but was well tolerated.</p> <p id="JCL-P-19">To the best of our knowledge, methylnaltrexone has not previously been tested in a cohort of patients with AP, and the proper dose and administration regimens have not been established in this setting. Daily or bidaily subcutaneous boluses of 0.15 mg/kg methylnaltrexone have consistently been shown to relieve opioid-induced constipation, aligning with the approved use for methylnaltrexone (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R13 R14 R33 R34">13,14,33,34</a></sup>). In previous studies, intravenous boluses of 0.3 mg/kg methylnaltrexone accelerated postoperative bowel recovery (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R35">35</a></sup>) and reduced transit times in healthy subjects (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R20">20</a></sup>). However, intravenous methylnaltrexone boluses of 0.15 mg/kg did not promote laxation in critical care patients on stable opioid treatment (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R18">18</a></sup>). The dose chosen for this study may have been inadequate for effective opioid antagonism in the gut. However, this is unlikely as methylnaltrexone has a significantly higher affinity for the µ-opioid receptor compared with conventional opioids, blocking up to 97% of morphine's effect on intestinal motility (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R36 R37">36,37</a></sup>). The continuous mode of delivery chosen for this study might have led to lower peak concentrations, potentially also affecting the effect of the drug. We chose to administer methylnaltrexone continuously to prevent adverse reactions, including abdominal cramps and nausea, which are commonly reported with the bolus regimens (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R13 R33">13,33</a></sup>). Throughout the study, we observed numerically higher morphine equivalent doses in the methylnaltrexone group compared with placebo. Since it is well established that methylnaltrexone has a restricted ability to cross the blood-brain barrier, it is unlikely that this is due to central opioid antagonism (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R21">21</a></sup>).</p> <p id="JCL-P-20">In this study, we found no difference in stool frequencies between patients receiving methylnaltrexone and placebo, contradicting the anticipated mode of action for methylnaltrexone. The premise of this study was that opioids may cause dysmotility, which could be one of the mechanisms to increase severity in AP. However, numerous potential modifiers of gastrointestinal motility are present in AP and were not controlled for in this study (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R38">38</a></sup>), potentially impacting bowel movements. In AP with critical illness, paralytic ileus may be caused by metabolic derangement, fluid imbalances, and severe infections (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R39">39</a></sup>). Preclinical studies have indicated that systemic inflammation, which is a hallmark of AP, can cause ileus in itself through chemokine secretion to the intestinal lumen (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R40 R41">40,41</a></sup>). Furthermore, dysmotility may result from neuron damage or gut hormone secretion in AP (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R42 R43">42,43</a></sup>). Since concurrent medical treatment was unrestricted in this study, factors such as laxative use may also have impacted gastrointestinal motility. Although dysmotility has been linked to severe AP, clinical evidence has also indicated that dysmotility is present even in mild cases (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R43 R44">43,44</a></sup>). This may be why we observe such a high need for laxatives in our study population, even in the methylnaltrexone group.</p> <p id="JCL-P-21">As discussed above, AP is a complex setting of coexisting conditions in which the role of endogenous and exogenous opioids remains incompletely understood. The safety of opioids in AP has been continuously debated since opioids can interfere with motility, intestinal and pancreatic secretion, tone in the sphincters, and inflammation in a negative manner. Retrospective clinical studies previously found that opioids increased the risk of 30-day mortality, organ-supportive treatment, longer admission length, and aggravated morphologic AP severity (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R4 R45 R46">4,45,46</a></sup>). By contrast, other studies indicated no difference in the risk of severe disease between opioids and other analgesics in AP (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R47 R48">47,48</a></sup>). Investigating the safety of opioids in AP through a randomized comparison with a placebo is ethically challenging due to potential harm to patients in the placebo arm and the predominant use of opioids as rescue analgesia in AP trials (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R49">49</a></sup>). We have previously shown that the peripheral effects of opioids can be antagonized by peripherally restricted opioid antagonists (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R50 R51 R52 R53">50–53</a></sup>). Although indirectly, this study did not support that opioids have peripheral harmful effects in AP.</p> <p id="JCL-P-22">A strength of our study was the prospective, randomized, and placebo-controlled trial design. Furthermore, the composition of our cohort aligned with previous reports on AP patients with regard to age, etiology, morbidity, and mortality (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R1 R54">1,54</a></sup>). There are several limitations. At baseline, we observed a 20-point higher PASS score in the methylnaltrexone group, indicating that our groups were not sufficiently balanced at randomization. However, the change-from-baseline sensitivity analysis gave the same results as the primary analysis. During the study, we removed the exclusion criteria of symptoms for more than 48 hours, as most screened patients were admitted to the hospital with longer-lasting pain. Ideally, treatment should be initiated directly on symptom onset, but this was not realistic as pain often develops over time, and many patients likely recover spontaneously. Approximately half of the patients in this study had mild AP despite being selected using the SIRS criteria, which aligns with prior findings on AP severity prediction accuracy (<sup><a class="ejp-citation-link js-ejp-citation-link" data-reference-links="R55">55</a></sup>). However, we do recognize that this high proportion of mild AP may have weakened the impact of methylnaltrexone on disease severity, potentially underpowering the study.</p> <p id="JCL-P-23">In summary, continuous intravenous methylnaltrexone infusions did not demonstrate superiority over placebo for reducing disease severity in AP patients with SIRS.</p> <h2 class="ejp-article-outline-heading" data-level="1" id="s5">CONFLICTS OF INTEREST</h2> <p id="JCL-P-24"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Guarantor of the article:</strong> Asbjørn Mohr Drewes, MD, PhD, DMSc.</p> <p id="JCL-P-25"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Specific author contributions:</strong> C.S.K., S.S.O., and A.M.D. had direct access to and verified the underlying data reported in this manuscript. C.S.K., M.E.C., S.N., M.B.H., M.B.M., L.B.J.N., O.T.U., J.B.F., S.S.O., and A.M.D.: conceptualization and methodology. C.S.K., M.E.C., S.N., M.B.H., M.B.M., L.B.J.N., I.M.H., C.S., C.E.L.N., A.J.A., S.P., L.S.S., O.T.U., J.B.F., S.S.O., and A.M.D.: investigation, resources, and validation. C.S.K., S.S.O., and A.M.D. supported by S.N., M.B.H., M.B.M., S.P., O.T.U., and J.B.F.: software, formal analysis, visualization, and data curation. C.S.K., S.S.O., and A.M.D.: supervision, project administration, and funding acquisition. C.S.K., S.S.O., and A.M.D.: writing—original draft. C.S.K., M.E.C., S.N., M.B.H., M.B.M., L.B.J.N., I.M.H., C.S., C.E.L.N., A.J.A., S.P., L.S.S., O.T.U., J.B.F., S.S.O., and A.M.D.: writing—review & editing including final approval.</p> <p id="JCL-P-26"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Financial support:</strong> The study was funded by The Novo Nordisk Foundation, grant#NNF19OC0057331. The Novo Nordisk Foundation had no role in the study design, data collection, data analysis, data interpretation, or writing the report.</p> <p id="JCL-P-27"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Potential competing interests:</strong> None to report.</p> <p id="JCL-P-28"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Clinical trial registration:</strong><span><a href="http://ClinicalTrials.gov" onclick="javascript:window.open('http://ClinicalTrials.gov');return false">ClinicalTrials.gov</a></span>, trial identification number: NCT04743570.</p> <p id="JCL-P-29"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Ethics:</strong> The study was approved by the North Denmark Region Committee on Health Research Ethics (Identifier: N-20200060) and the Danish Medicines Agency (EudraCT identifier: 2020-002313-18) and followed the principles of the Helsinki Declaration. All participants gave written informed consent.</p> <p id="JCL-P-30"><strong xmlns:mrws="http://webservices.ovid.com/mrws/1.0">Data availability statement:</strong> Data that support the findings of this trial are available from the corresponding author upon reasonable request.<article class="article-boxed-text"><p id="B1"><strong>Study Highlights</strong></p> <h4 class="ejp-article-outline-heading" data-level="3" id="JCL4">WHAT IS KNOWN</h4> <p id="JCL-P-31"> <ul id="-1" class="wk-article__list wk-article__list--plain"> <li class="wk-article__list-item wk-article__list-item--plain">✓ Opioid sparing is often recommended for acute pancreatitis (AP) pain due to safety concerns.</li> <li class="wk-article__list-item wk-article__list-item--plain">✓ Methylnaltrexone, a peripheral µ-opioid receptor antagonist, may counteract peripheral effects of opioid administration without affecting analgesia.</li> <li class="wk-article__list-item wk-article__list-item--plain">✓ Methylnaltrexone has never been investigated in AP.</li> </ul> </p> <h4 class="ejp-article-outline-heading" data-level="3" id="JCL5">WHAT IS NEW HERE</h4> <p id="JCL-P-35"> <ul id="-1" class="wk-article__list wk-article__list--plain"> <li class="wk-article__list-item wk-article__list-item--plain">✓ Forty-eight hours of continuous intravenous methylnaltrexone treatment did not achieve superiority over placebo for reducing the severity of AP, as measured by the Pancreatitis Activity Scoring System score.</li> <li class="wk-article__list-item wk-article__list-item--plain">✓ Methylnaltrexone treatment was well tolerated by the patients in this study.</li> </ul> </p></article></p></section><section id="article-references" class="article-references js-article-references"><h2 class="ejp-article-outline-heading" data-level="1" id="JCL6">ACKNOWLEDGMENTS</h2> <p id="JCL-P-38">We acknowledge the nursing staff at our 4 study sites and the patients who opted to participate in the study. We also wish to recognize our collaborators for their invaluable contributions. Annette Aggerholm Overbye (Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark), Ann Hauberg (Department of Gastrointestinal Surgery, Aalborg University Hospital, Denmark), Mohamad Ali Abdul Ghani (Department of Surgery, Odense University Hospital, Svendborg, Denmark), Sandie Jönch Møller (Digestive Disease Center K, Bispebjerg University Hospital of Copenhagen, Denmark), Mette Brogaard Barrit (Digestive Disease Center K, Bispebjerg University Hospital of Copenhagen, Denmark), Karen Lisa Hilsted (Gastrounit, Hvidovre University Hospital of Copenhagen, Denmark), Camilla Møller Vorsholt (Gastrounit, Hvidovre University Hospital of Copenhagen, Denmark), Joy Stinne Timmner (Gastrounit, Hvidovre University Hospital of Copenhagen, Denmark), Morten Laksáfoss Lauritsen (Gastrounit, Hvidovre University Hospital of Copenhagen, Denmark).</p> <h2 class="ejp-article-outline-heading" data-level="1" id="JCL-L-2">REFERENCES</h2> <div id="R1" class="article-references__item js-article-reference">1. 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