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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ftdoajarticles:oai:doaj.org/article:f0c9670205b24fe7b3d4199388054b07 2023-05-15T15:15:05+02:00 Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. Inge Wagenaar Erik Post Wim Brandsma Bob Bowers Khorshed Alam Vanaja Shetty Vivek Pai Sajid Husain Cita Rosita Sigit Prakoeswa Linda Astari Deanna Hagge Mahesh Shah Kapil Neupane Krishna Bahadur Tamang TENLEP study group Peter Nicholls Jan Hendrik Richardus 2017-10-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0005952 https://doaj.org/article/f0c9670205b24fe7b3d4199388054b07 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC5643133?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0005952 https://doaj.org/article/f0c9670205b24fe7b3d4199388054b07 PLoS Neglected Tropical Diseases, Vol 11, Iss 10, p e0005952 (2017) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2017 ftdoajarticles https://doi.org/10.1371/journal.pntd.0005952 2022-12-31T03:38:12Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 11 10 e0005952 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Inge Wagenaar Erik Post Wim Brandsma Bob Bowers Khorshed Alam Vanaja Shetty Vivek Pai Sajid Husain Cita Rosita Sigit Prakoeswa Linda Astari Deanna Hagge Mahesh Shah Kapil Neupane Krishna Bahadur Tamang TENLEP study group Peter Nicholls Jan Hendrik Richardus Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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. |
format |
Article in Journal/Newspaper |
author |
Inge Wagenaar Erik Post Wim Brandsma Bob Bowers Khorshed Alam Vanaja Shetty Vivek Pai Sajid Husain Cita Rosita Sigit Prakoeswa Linda Astari Deanna Hagge Mahesh Shah Kapil Neupane Krishna Bahadur Tamang TENLEP study group Peter Nicholls Jan Hendrik Richardus |
author_facet |
Inge Wagenaar Erik Post Wim Brandsma Bob Bowers Khorshed Alam Vanaja Shetty Vivek Pai Sajid Husain Cita Rosita Sigit Prakoeswa Linda Astari Deanna Hagge Mahesh Shah Kapil Neupane Krishna Bahadur Tamang TENLEP study group Peter Nicholls Jan Hendrik Richardus |
author_sort |
Inge Wagenaar |
title |
Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
title_short |
Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
title_full |
Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
title_fullStr |
Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
title_full_unstemmed |
Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial. |
title_sort |
effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: a randomized controlled trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2017 |
url |
https://doi.org/10.1371/journal.pntd.0005952 https://doaj.org/article/f0c9670205b24fe7b3d4199388054b07 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 11, Iss 10, p e0005952 (2017) |
op_relation |
http://europepmc.org/articles/PMC5643133?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0005952 https://doaj.org/article/f0c9670205b24fe7b3d4199388054b07 |
op_doi |
https://doi.org/10.1371/journal.pntd.0005952 |
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PLOS Neglected Tropical Diseases |
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11 |
container_issue |
10 |
container_start_page |
e0005952 |
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