{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T18:40:39Z","timestamp":1762540839803,"version":"3.40.5"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,6,24]],"date-time":"2022-06-24T00:00:00Z","timestamp":1656028800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Muscle and Nerve"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction\/Aims<\/jats:title><jats:p>Peripheral neuropathies commonly affect quality of life of patients due to pain, sleep disturbances, and fatigue, although trials have not adequately explored these domains of care. The aim of this study was to assess the impact of nortriptyline, duloxetine, pregabalin, and mexiletine on pain, sleep, and fatigue in patients diagnosed with cryptogenic sensory polyneuropathy (CSPN).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We implemented a Bayesian adaptive design to perform a 12\u2010wk multisite, randomized, prospective, open\u2010label comparative effectiveness study in 402 CSPN patients. Participants received either nortriptyline (<jats:italic>n<\/jats:italic>\u00a0=\u2009134), duloxetine (<jats:italic>n<\/jats:italic>\u00a0=\u2009126), pregabalin (<jats:italic>n<\/jats:italic>\u00a0=\u200973), or mexiletine (<jats:italic>n<\/jats:italic>\u00a0=\u200969). At prespecified analysis timepoints, secondary outcomes, Patient Reported Outcomes Measurement Information System (PROMIS) surveys including Short Form (SF)\u201012, pain interference, fatigue, and sleep disturbance, were collected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mexiletine had the highest quit rate (58%) due to gastrointestinal side effects, while nortriptyline (38%) and duloxetine (38%) had the lowest quit rates. If tolerated for the full 12\u2009wk of the study, mexiletine had the highest probability (&gt;90%) of positive outcomes for improvements in pain interference and fatigue. There was no significant difference among the medications for sleep disturbance or SF\u201012 scores. Adverse events and lack of efficacy were the two most common reasons for cessation of therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Physicians caring for patients with CSPN should consider mexiletine to address pain and fatigue, although nortriptyline and duloxetine are better medications to trial first since they are better tolerated. Future research should compare other commonly used medications for CSPN to determine evidence\u2010based treatment strategies.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mus.27637","type":"journal-article","created":{"date-parts":[[2022,5,19]],"date-time":"2022-05-19T04:49:08Z","timestamp":1652935748000},"page":"404-410","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A secondary analysis of PAIN\u2010CONTRoLS: Pain's impact on sleep, fatigue, and activities of daily living"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4702-9380","authenticated-orcid":false,"given":"Salman F.","family":"Bhai","sequence":"first","affiliation":[{"name":"Department of Neurology The University of Texas Southwestern Medical Center Dallas Texas USA"},{"name":"Neuromuscular Center Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Dallas Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Brown","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science The University of Kansas Medical Center Kansas City Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Byron","family":"Gajewski","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Data Science The University of Kansas Medical Center Kansas City Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim S.","family":"Kimminau","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine The University of Missouri School of Medicine Columbia Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lemuel R.","family":"Waitman","sequence":"additional","affiliation":[{"name":"Department of Health Management and Informatics The University of Missouri School of Medicine Columbia Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mamatha","family":"Pasnoor","sequence":"additional","affiliation":[{"name":"Department of Neurology The University of Kansas Medical Center Kansas City Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard J.","family":"Barohn","sequence":"additional","affiliation":[{"name":"Department of Neurology The University of Missouri School of Medicine Columbia Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the PAIN\u2010CONTRoLS Study Team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,6,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-2008-1040857"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2013.02.001"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2013.01.008"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-2008-1040866"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.56.5.540"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.3109\/00207454.2013.782026"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.57.12.1525"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000003882"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.3109\/00207454.2011.582238"},{"key":"e_1_2_11_11_1","first-page":"CD007115","article-title":"Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia","volume":"1","author":"Lunn MP","year":"2014","journal-title":"Cochrane Database Syst Review"},{"key":"e_1_2_11_12_1","first-page":"CD007076","article-title":"Pregabalin for neuropathic pain in adults","volume":"1","author":"Derry S","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(88)90999-3"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2020.2590"},{"key":"e_1_2_11_15_1","unstructured":"Patient\u2010Centered Outcomes Research Institute.Comparing four medicines to treat pain from cryptogenic sensory polyneuropathy (CSPN)\u2014the PAIN\u2010CONTRoLS study. 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