Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial
While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is mor...
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| creator | Wagenaar, Inge Post, Erik Brandsma, Wim Bowers, Bob Alam, Khorshed Shetty, Vanaja Pai, Vivek Husain, Sajid Sigit Prakoeswa, Cita Rosita Astari, Linda Hagge, Deanna Shah, Mahesh Neupane, Kapil Tamang, Krishna Bahadur Nicholls, Peter Richardus, Jan Hendrik |
| description | While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function.
In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI ( |
| doi_str_mv | 10.1371/journal.pntd.0005952 |
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In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported.
We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm.
In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0005952</identifier><identifier>PMID: 28976976</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Adult ; Analysis ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - therapeutic use ; Biology and Life Sciences ; Body weight ; Care and treatment ; Clinical trials ; Dosage and administration ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Duration ; Edema ; Female ; Hospitals ; Humans ; Impairment ; Laboratories ; Leprosy ; Leprosy - complications ; Leprosy - drug therapy ; Male ; Medicine ; Medicine and Health Sciences ; Middle Aged ; Nerves ; Nervous system diseases ; Neuropathy ; Patients ; Peripheral Nervous System Diseases - drug therapy ; Peripheral Nervous System Diseases - etiology ; Prednisolone ; Prednisolone - administration & dosage ; Prednisolone - therapeutic use ; Public health ; Randomization ; Research and Analysis Methods ; Skeletal muscle ; Supervision ; Testing ; Treatment outcome ; Tropical diseases ; Tumor necrosis factor-TNF ; Young Adult</subject><ispartof>PLoS neglected tropical diseases, 2017-10, Vol.11 (10), p.e0005952-e0005952</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>2017 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Wagenaar I, Post E, Brandsma W, Bowers B, Alam K, Shetty V, et al. (2017) Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. PLoS Negl Trop Dis11(10): e0005952. https://doi.org/10.1371/journal.pntd.0005952</rights><rights>2017 Wagenaar et al 2017 Wagenaar et al</rights><rights>2017 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Wagenaar I, Post E, Brandsma W, Bowers B, Alam K, Shetty V, et al. (2017) Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. PLoS Negl Trop Dis11(10): e0005952. https://doi.org/10.1371/journal.pntd.0005952</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c624t-c797f4aa4ad27b9d1c781e907f4f55548623ee32068237e6cd4809ecedd4815a3</citedby><cites>FETCH-LOGICAL-c624t-c797f4aa4ad27b9d1c781e907f4f55548623ee32068237e6cd4809ecedd4815a3</cites><orcidid>0000-0002-6329-7273</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5643133/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5643133/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28976976$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Vinetz, Joseph M.</contributor><creatorcontrib>Wagenaar, Inge</creatorcontrib><creatorcontrib>Post, Erik</creatorcontrib><creatorcontrib>Brandsma, Wim</creatorcontrib><creatorcontrib>Bowers, Bob</creatorcontrib><creatorcontrib>Alam, Khorshed</creatorcontrib><creatorcontrib>Shetty, Vanaja</creatorcontrib><creatorcontrib>Pai, Vivek</creatorcontrib><creatorcontrib>Husain, Sajid</creatorcontrib><creatorcontrib>Sigit Prakoeswa, Cita Rosita</creatorcontrib><creatorcontrib>Astari, Linda</creatorcontrib><creatorcontrib>Hagge, Deanna</creatorcontrib><creatorcontrib>Shah, Mahesh</creatorcontrib><creatorcontrib>Neupane, Kapil</creatorcontrib><creatorcontrib>Tamang, Krishna Bahadur</creatorcontrib><creatorcontrib>Nicholls, Peter</creatorcontrib><creatorcontrib>Richardus, Jan Hendrik</creatorcontrib><creatorcontrib>TENLEP study group</creatorcontrib><creatorcontrib>The TENLEP study group</creatorcontrib><title>Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function.
In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported.
We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm.
In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Analysis</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>Biology and Life Sciences</subject><subject>Body weight</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Dosage and administration</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Duration</subject><subject>Edema</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Impairment</subject><subject>Laboratories</subject><subject>Leprosy</subject><subject>Leprosy - complications</subject><subject>Leprosy - drug therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Nerves</subject><subject>Nervous system diseases</subject><subject>Neuropathy</subject><subject>Patients</subject><subject>Peripheral Nervous System Diseases - drug therapy</subject><subject>Peripheral Nervous System Diseases - etiology</subject><subject>Prednisolone</subject><subject>Prednisolone - administration & dosage</subject><subject>Prednisolone - therapeutic use</subject><subject>Public health</subject><subject>Randomization</subject><subject>Research and Analysis Methods</subject><subject>Skeletal muscle</subject><subject>Supervision</subject><subject>Testing</subject><subject>Treatment outcome</subject><subject>Tropical diseases</subject><subject>Tumor necrosis factor-TNF</subject><subject>Young Adult</subject><issn>1935-2735</issn><issn>1935-2727</issn><issn>1935-2735</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNptUl2LEzEUHURx1-o_EA0I4ktrPibJjA_Csqy6sOCLPoc0c6dNzSRjMtNl_Q3-aDNtd2llSSA3N-ee-5FTFK8JXhAmycdNGKPXbtH7oVlgjHnN6ZPinNSMz6lk_OmRfVa8SGmzw1TkeXFGq1qKvM-Lv1dtC2awW_CQEgotYhRtIaYxIYrRLcCvnbeP0HibggsekPXIQR9DukO9Hiz4IaFbO6xRBJMvyEPcAmpHn4mDR7brtY1dfvmELlDUvgmd_QMNMsEPMTiXzSFa7V4Wz1rtErw6nLPi55erH5ff5jffv15fXtzMjaDlMDeylm2pdakbKpd1Q4ysCNQ4O1vOeVkJygAYxaKiTIIwTVnhOpfWZINwzWbF2z1v70JSh0EmRWrBCS5pzTPieo9ogt6oPtpOxzsVtFU7R4grpeNgjQPVYlMLiSnmS1q2IJesKUlds6rCvFximbk-H7KNyw6aaUJRuxPS0xdv12oVtoqLkhHGMsGHA0EMv0dIg-psMuCc9hDGqe5SCiKYmOp-9x_08e4OqJXODVjfhpzXTKTqghMqpMA59axYPILKq4HO5q-D1mb_ScD7o4A1aDess2LGSQTpFFjugSZrKEVoH4ZBsJrEfV-1msStDuLOYW-OB_kQdK9m9g9DD_dK</recordid><startdate>20171004</startdate><enddate>20171004</enddate><creator>Wagenaar, Inge</creator><creator>Post, Erik</creator><creator>Brandsma, Wim</creator><creator>Bowers, Bob</creator><creator>Alam, Khorshed</creator><creator>Shetty, Vanaja</creator><creator>Pai, Vivek</creator><creator>Husain, Sajid</creator><creator>Sigit Prakoeswa, Cita Rosita</creator><creator>Astari, Linda</creator><creator>Hagge, Deanna</creator><creator>Shah, Mahesh</creator><creator>Neupane, Kapil</creator><creator>Tamang, Krishna Bahadur</creator><creator>Nicholls, Peter</creator><creator>Richardus, Jan Hendrik</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7SS</scope><scope>7T2</scope><scope>7T7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>F1W</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>H95</scope><scope>H97</scope><scope>K9.</scope><scope>L.G</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-6329-7273</orcidid></search><sort><creationdate>20171004</creationdate><title>Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial</title><author>Wagenaar, Inge ; Post, Erik ; Brandsma, Wim ; Bowers, Bob ; Alam, Khorshed ; Shetty, Vanaja ; Pai, Vivek ; Husain, Sajid ; Sigit Prakoeswa, Cita Rosita ; Astari, Linda ; Hagge, Deanna ; Shah, Mahesh ; Neupane, Kapil ; Tamang, Krishna Bahadur ; Nicholls, Peter ; Richardus, Jan Hendrik</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c624t-c797f4aa4ad27b9d1c781e907f4f55548623ee32068237e6cd4809ecedd4815a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Analysis</topic><topic>Anti-Inflammatory Agents - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PLoS neglected tropical diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wagenaar, Inge</au><au>Post, Erik</au><au>Brandsma, Wim</au><au>Bowers, Bob</au><au>Alam, Khorshed</au><au>Shetty, Vanaja</au><au>Pai, Vivek</au><au>Husain, Sajid</au><au>Sigit Prakoeswa, Cita Rosita</au><au>Astari, Linda</au><au>Hagge, Deanna</au><au>Shah, Mahesh</au><au>Neupane, Kapil</au><au>Tamang, Krishna Bahadur</au><au>Nicholls, Peter</au><au>Richardus, Jan Hendrik</au><au>Vinetz, Joseph M.</au><aucorp>TENLEP study group</aucorp><aucorp>The TENLEP study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial</atitle><jtitle>PLoS neglected tropical diseases</jtitle><addtitle>PLoS Negl Trop Dis</addtitle><date>2017-10-04</date><risdate>2017</risdate><volume>11</volume><issue>10</issue><spage>e0005952</spage><epage>e0005952</epage><pages>e0005952-e0005952</pages><issn>1935-2735</issn><issn>1935-2727</issn><eissn>1935-2735</eissn><abstract>While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function.
In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported.
We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm.
In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28976976</pmid><doi>10.1371/journal.pntd.0005952</doi><orcidid>https://orcid.org/0000-0002-6329-7273</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1935-2735 |
| ispartof | PLoS neglected tropical diseases, 2017-10, Vol.11 (10), p.e0005952-e0005952 |
| issn | 1935-2735 1935-2727 1935-2735 |
| language | eng |
| recordid | cdi_plos_journals_1965104295 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Adolescent Adult Analysis Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - therapeutic use Biology and Life Sciences Body weight Care and treatment Clinical trials Dosage and administration Double-Blind Method Drug Administration Schedule Drug therapy Duration Edema Female Hospitals Humans Impairment Laboratories Leprosy Leprosy - complications Leprosy - drug therapy Male Medicine Medicine and Health Sciences Middle Aged Nerves Nervous system diseases Neuropathy Patients Peripheral Nervous System Diseases - drug therapy Peripheral Nervous System Diseases - etiology Prednisolone Prednisolone - administration & dosage Prednisolone - therapeutic use Public health Randomization Research and Analysis Methods Skeletal muscle Supervision Testing Treatment outcome Tropical diseases Tumor necrosis factor-TNF Young Adult |
| title | Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial |
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