{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T04:13:14Z","timestamp":1772856794926,"version":"3.50.1"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T00:00:00Z","timestamp":1630713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Almirall S.A."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,4,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To compare the effectiveness, safety, and tolerability of add-on nabiximols (NBX) oromucosal spray vs typical oral long-acting opioid (LAO) analgesics in patients with severe (\u00b1 chronic) peripheral neuropathic back pain poorly responsive to other treatments.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Retrospective analysis of anonymized, propensity score\u2013matched data from the German Pain e-Registry of adult outpatients who initiated NBX or LAO between March 2017 and March 2020.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Data were analyzed from propensity score\u2013matched patients treated with NBX (n\u2009=\u2009655) or LAO (n\u2009=\u2009655): mean age \u224851\u2009years; 57% female; mean pain duration \u22482.6\u2009years; chronic pain 61%; severe dysfunctional pain 93%. At 6\u2009months, NBX was noninferior to LAO for overall symptom relief, based on the least-squares mean difference between cohorts in change from baseline in patient-reported, pain-related aggregated nine-item scale scores (\u221227.84%; 95% confidence interval [CI] \u221229.71 to \u221225.96; P\u2009&amp;lt;\u20090.001) and individual pain-related scale scores. Subsequent prespecified superiority analysis of the primary endpoint showed that NBX was superior to LAO: all secondary endpoints measuring symptoms of pain and physical function improved significantly with NBX and LAO, with between-group differences favoring NBX (all P\u2009&amp;lt;\u20090.001). Fewer patients treated with NBX than LAO experienced treatment-related adverse events (25.5% vs 76.0%; P\u2009&amp;lt;\u20090.001) or discontinued treatment because of treatment-related adverse events (7.9% vs 29.3%; P\u2009&amp;lt;\u20090.001).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Within study limitations (e.g., observational design, all potential biases), add-on NBX was superior to and better tolerated than add-on treatment with typical oral LAO analgesics in patients with neuropathic back pain inadequately controlled by recommended\/established systemic therapies.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/pm\/pnab263","type":"journal-article","created":{"date-parts":[[2021,9,4]],"date-time":"2021-09-04T14:22:37Z","timestamp":1630765357000},"page":"745-760","source":"Crossref","is-referenced-by-count":11,"title":["Effectiveness, Safety, and Tolerability of Nabiximols Oromucosal Spray vs Typical Oral Long-Acting Opioid Analgesics in Patients with Severe Neuropathic Back Pain: Analysis of 6-Month Real-World Data from the German Pain e-Registry"],"prefix":"10.1093","volume":"23","author":[{"suffix":"MD","given":"Michael A","family":"Ueberall","sequence":"first","affiliation":[{"name":"Institute of Neurological Sciences, Nuernberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"MD","given":"Carlos","family":"Vila Silv\u00e1n","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Almirall S.A., Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ute","family":"Essner","sequence":"additional","affiliation":[{"name":"O. Meany Consultancy GmbH, Hamburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"MD","given":"Gerhard H H","family":"Mueller-Schwefe","sequence":"additional","affiliation":[{"name":"Schmerz- und Palliativzentrum G\u00f6ppingen, G\u00f6ppingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,9,4]]},"reference":[{"issue":"6","key":"2022040813461018000_pnab263-B1","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1002\/ejp.838","article-title":"Neuropathic low back pain in clinical practice","volume":"20","author":"Baron","year":"2016","journal-title":"Eur J Pain"},{"issue":"6","key":"2022040813461018000_pnab263-B2","doi-asserted-by":"crossref","first-page":"299","DOI":"10.21037\/atm.2020.02.175","article-title":"Global low back pain prevalence and years lived with disability from 1990 to 2017: Estimates from the Global Burden of Disease Study 2017","volume":"8","author":"Wu","year":"2020","journal-title":"Ann Transl Med"},{"issue":"10","key":"2022040813461018000_pnab263-B3","doi-asserted-by":"crossref","first-page":"1911","DOI":"10.1185\/030079906X132488","article-title":"painDETECT: A new screening questionnaire to identify neuropathic components in patients with back pain","volume":"22","author":"Freynhagen","year":"2006","journal-title":"Curr Med Res Opin"},{"issue":"3","key":"2022040813461018000_pnab263-B4","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1185\/030079906X89874","article-title":"Screening of neuropathic pain components in patients with chronic back pain associated with nerve root compression: A prospective observational pilot study (MIPORT)","volume":"22","author":"Freynhagen","year":"2006","journal-title":"Curr Med Res Opin"},{"issue":"4","key":"2022040813461018000_pnab263-B5","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1016\/j.jpain.2005.11.008","article-title":"The epidemiology of chronic pain of predominantly neuropathic origin. 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