Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus

Detalhes bibliográficos
Autor(a) principal: Trevisani, Virgínia Fernandes Moça [UNIFESP]
Data de Publicação: 2013
Outros Autores: Castro, Aldemar Araujo [UNIFESP], Neves Neto, Joao Ferreira [UNIFESP], Atallah, Álvaro Nagib [UNIFESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://dx.doi.org/10.1002/14651858.CD002265.pub3
http://repositorio.unifesp.br/handle/11600/35630
Resumo: BackgroundNeuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.ObjectivesTo assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, SCOPUS and WHO up to and including June 2012. We sought additional articles through handsearching in relevant journals as well as contact with experts. There were no language restrictions.Selection criteriaWe included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.Data collection and analysisTwo review authors independently extracted, assessed and cross-checked data. We produced a 'Summary of findings' table. We presented dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs).Main resultsWe did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). the median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.Authors' conclusionsThis systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change.
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spelling Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosusCyclophosphamide [therapeutic use]Delirium, Dementia, Amnestic, Cognitive Disorders [drug therapy; etiology]Immunosuppressive Agents [therapeutic use]Lupus Erythematosus, Systemic [complications; drug therapy]Methylprednisolone [therapeutic use]Neuroprotective Agents [therapeutic use]Seizures [drug therapy; etiology]HumansBackgroundNeuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.ObjectivesTo assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, SCOPUS and WHO up to and including June 2012. We sought additional articles through handsearching in relevant journals as well as contact with experts. There were no language restrictions.Selection criteriaWe included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.Data collection and analysisTwo review authors independently extracted, assessed and cross-checked data. We produced a 'Summary of findings' table. We presented dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs).Main resultsWe did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). the median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.Authors' conclusionsThis systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change.Universidade Federal de São Paulo, BR-04664150 São Paulo, BrazilState Univ Heath Sci, Dept Publ Hlth, Maceio, BrazilUniversidade Federal de São Paulo, Escola Paulista Med, Brazilian Cochrane Ctr, BR-04664150 São Paulo, BrazilUniversidade Federal de São Paulo, BR-04664150 São Paulo, BrazilUniversidade Federal de São Paulo, Escola Paulista Med, Brazilian Cochrane Ctr, BR-04664150 São Paulo, BrazilWeb of ScienceClinical Trials and Meta-analysis Unit, Federal University of São Paulo, BrazilUniversidade Santo Amaro, BrazilWiley-BlackwellUniversidade Federal de São Paulo (UNIFESP)State Univ Heath SciTrevisani, Virgínia Fernandes Moça [UNIFESP]Castro, Aldemar Araujo [UNIFESP]Neves Neto, Joao Ferreira [UNIFESP]Atallah, Álvaro Nagib [UNIFESP]2016-01-24T14:28:10Z2016-01-24T14:28:10Z2013-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion33http://dx.doi.org/10.1002/14651858.CD002265.pub3Cochrane Database of Systematic Reviews. Hoboken: Wiley-Blackwell, n. 2, 33 p., 2013.10.1002/14651858.CD002265.pub31469-493Xhttp://repositorio.unifesp.br/handle/11600/35630WOS:000315461200018engCochrane Database of Systematic Reviewsinfo:eu-repo/semantics/openAccesshttp://olabout.wiley.com/WileyCDA/Section/id-406071.htmlreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2023-03-27T11:17:54Zoai:repositorio.unifesp.br/:11600/35630Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652023-03-27T11:17:54Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
title Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
spellingShingle Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
Trevisani, Virgínia Fernandes Moça [UNIFESP]
Cyclophosphamide [therapeutic use]
Delirium, Dementia, Amnestic, Cognitive Disorders [drug therapy; etiology]
Immunosuppressive Agents [therapeutic use]
Lupus Erythematosus, Systemic [complications; drug therapy]
Methylprednisolone [therapeutic use]
Neuroprotective Agents [therapeutic use]
Seizures [drug therapy; etiology]
Humans
title_short Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
title_full Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
title_fullStr Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
title_full_unstemmed Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
title_sort Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus
author Trevisani, Virgínia Fernandes Moça [UNIFESP]
author_facet Trevisani, Virgínia Fernandes Moça [UNIFESP]
Castro, Aldemar Araujo [UNIFESP]
Neves Neto, Joao Ferreira [UNIFESP]
Atallah, Álvaro Nagib [UNIFESP]
author_role author
author2 Castro, Aldemar Araujo [UNIFESP]
Neves Neto, Joao Ferreira [UNIFESP]
Atallah, Álvaro Nagib [UNIFESP]
author2_role author
author
author
dc.contributor.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
State Univ Heath Sci
dc.contributor.author.fl_str_mv Trevisani, Virgínia Fernandes Moça [UNIFESP]
Castro, Aldemar Araujo [UNIFESP]
Neves Neto, Joao Ferreira [UNIFESP]
Atallah, Álvaro Nagib [UNIFESP]
dc.subject.por.fl_str_mv Cyclophosphamide [therapeutic use]
Delirium, Dementia, Amnestic, Cognitive Disorders [drug therapy; etiology]
Immunosuppressive Agents [therapeutic use]
Lupus Erythematosus, Systemic [complications; drug therapy]
Methylprednisolone [therapeutic use]
Neuroprotective Agents [therapeutic use]
Seizures [drug therapy; etiology]
Humans
topic Cyclophosphamide [therapeutic use]
Delirium, Dementia, Amnestic, Cognitive Disorders [drug therapy; etiology]
Immunosuppressive Agents [therapeutic use]
Lupus Erythematosus, Systemic [complications; drug therapy]
Methylprednisolone [therapeutic use]
Neuroprotective Agents [therapeutic use]
Seizures [drug therapy; etiology]
Humans
description BackgroundNeuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.ObjectivesTo assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, SCOPUS and WHO up to and including June 2012. We sought additional articles through handsearching in relevant journals as well as contact with experts. There were no language restrictions.Selection criteriaWe included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.Data collection and analysisTwo review authors independently extracted, assessed and cross-checked data. We produced a 'Summary of findings' table. We presented dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs).Main resultsWe did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). the median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.Authors' conclusionsThis systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change.
publishDate 2013
dc.date.none.fl_str_mv 2013-01-01
2016-01-24T14:28:10Z
2016-01-24T14:28:10Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1002/14651858.CD002265.pub3
Cochrane Database of Systematic Reviews. Hoboken: Wiley-Blackwell, n. 2, 33 p., 2013.
10.1002/14651858.CD002265.pub3
1469-493X
http://repositorio.unifesp.br/handle/11600/35630
WOS:000315461200018
url http://dx.doi.org/10.1002/14651858.CD002265.pub3
http://repositorio.unifesp.br/handle/11600/35630
identifier_str_mv Cochrane Database of Systematic Reviews. Hoboken: Wiley-Blackwell, n. 2, 33 p., 2013.
10.1002/14651858.CD002265.pub3
1469-493X
WOS:000315461200018
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Cochrane Database of Systematic Reviews
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dc.format.none.fl_str_mv 33
dc.publisher.none.fl_str_mv Wiley-Blackwell
publisher.none.fl_str_mv Wiley-Blackwell
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
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