The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis

Detalhes bibliográficos
Autor(a) principal: Cota, Gláucia Fernandes
Data de Publicação: 2016
Outros Autores: Sousa, Marcos Roberto de, Fereguetti, Tatiani Oliveira, Saleme, Priscila Said, Alvarisa, Thais Kawagoe, Rabello, Ana Lucia Teles
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/15014
Resumo: Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Investigação Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil
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spelling Cota, Gláucia FernandesSousa, Marcos Roberto deFereguetti, Tatiani OliveiraSaleme, Priscila SaidAlvarisa, Thais KawagoeRabello, Ana Lucia Teles2016-07-20T19:20:34Z2016-07-20T19:20:34Z2016COTA, Gláucia Fernandes et al. The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis. PLoS One, vol. 11, n. 2, p. e0149697, 20161932-6203https://www.arca.fiocruz.br/handle/icict/1501410.1371/journal.pone.0149697engPublic Library of ScienceThe Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Investigação Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilUniversidade Federal de Minas Gerais. Programa de Pos –Graduação em Ciencias da Saude Adulta. Belo Horizonte, MG, BrasilFundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, BrasilFundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, BrasilFundação Hospitalar do Estado de Minas Gerais. Hospital Eduardo de Menezes. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Investigação Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, BrasilINTRODUCTION: There are few drugs with proven efficacy in cutaneous leishmaniasis (CL), and pentavalent antimonial derivatives are still the main first-line therapeutic agents worldwide, despite their recognized high toxicities. Randomized controlled clinical trials assessing the efficacy and safety of new therapeutic modalities are of high priority, and the definition of the design of such trials raises debate about the use of placebo as a comparator. To support the use of placebo as a comparator, two main points need to be addressed: 1--the cure rate without any therapeutic intervention and 2--the damage caused by CL and its impact on patients. OBJECTIVE The aim of this study was to systematically assess the spontaneous cure rate for American CL and to broaden the discussion about placebo use in CL trials. METHODS: The PRISMA guidelines for systematic reviews and the Cochrane manual were followed. The sources used were the PubMed and LILACS databases. Studies were included if they reported cure rates using placebo or no treatment in American CL. RESULTS: Thirteen studies of a total of 352 patients were ultimately included in this review. The summarized global cure rates for all Leishmania species according to the intention-to-treat analyses performed at approximately three ("initial cure") and nine ("definitive cure") months after "no treatment" or placebo use were 26% (CI95%: 16 to 40%) and 26% (CI95%:16 to 38%), respectively. Notably, a significantly lower cure rate was observed for L. braziliensis infection (6.4%, CI95%:0.2 to 20%) than for L. mexicana infection (44%, CI95%:19 to 72%), p = 0.002. Of note, relapse occurred in 20% of patients with initial healing (CI95%:9.2 to 38.9%). CONCLUSION: These results clearly demonstrate a low spontaneous cure rate following no-treatment or placebo use, confirming that this strategy for the control group in CL studies expose patients to greater morbidity, especially for CL caused by L. braziliensis. Therefore, from this point, the crucial question to consider regarding placebo use is the seriousness of the suffering caused by this disease.cutaneous leishmaniasisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/15014/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Cota_Gláucia_The Cure_CPqRR_2016.PDFve_Cota_Gláucia_The Cure_CPqRR_2016.PDFapplication/pdf902544https://www.arca.fiocruz.br/bitstream/icict/15014/2/ve_Cota_Gl%c3%a1ucia_The%20Cure_CPqRR_2016.PDF0d158ae179ad44c321f00ac633ee15d0MD52TEXTve_Cota_Gláucia_The Cure_CPqRR_2016.PDF.txtve_Cota_Gláucia_The Cure_CPqRR_2016.PDF.txtExtracted texttext/plain51492https://www.arca.fiocruz.br/bitstream/icict/15014/3/ve_Cota_Gl%c3%a1ucia_The%20Cure_CPqRR_2016.PDF.txt9abc24af0c7180717488c815e321403fMD53icict/150142019-06-19 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dc.title.pt_BR.fl_str_mv The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
title The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
spellingShingle The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
Cota, Gláucia Fernandes
cutaneous leishmaniasis
title_short The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
title_full The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
title_fullStr The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
title_full_unstemmed The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
title_sort The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis
author Cota, Gláucia Fernandes
author_facet Cota, Gláucia Fernandes
Sousa, Marcos Roberto de
Fereguetti, Tatiani Oliveira
Saleme, Priscila Said
Alvarisa, Thais Kawagoe
Rabello, Ana Lucia Teles
author_role author
author2 Sousa, Marcos Roberto de
Fereguetti, Tatiani Oliveira
Saleme, Priscila Said
Alvarisa, Thais Kawagoe
Rabello, Ana Lucia Teles
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Cota, Gláucia Fernandes
Sousa, Marcos Roberto de
Fereguetti, Tatiani Oliveira
Saleme, Priscila Said
Alvarisa, Thais Kawagoe
Rabello, Ana Lucia Teles
dc.subject.en.pt_BR.fl_str_mv cutaneous leishmaniasis
topic cutaneous leishmaniasis
description Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Investigação Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil
publishDate 2016
dc.date.accessioned.fl_str_mv 2016-07-20T19:20:34Z
dc.date.available.fl_str_mv 2016-07-20T19:20:34Z
dc.date.issued.fl_str_mv 2016
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv COTA, Gláucia Fernandes et al. The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis. PLoS One, vol. 11, n. 2, p. e0149697, 2016
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/15014
dc.identifier.issn.pt_BR.fl_str_mv 1932-6203
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pone.0149697
identifier_str_mv COTA, Gláucia Fernandes et al. The Cure Rate after Placebo or No Therapy in American Cutaneous Leishmaniasis: A Systematic Review and Meta-Analysis. PLoS One, vol. 11, n. 2, p. e0149697, 2016
1932-6203
10.1371/journal.pone.0149697
url https://www.arca.fiocruz.br/handle/icict/15014
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
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