Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura

Detalhes bibliográficos
Autor(a) principal: Rocha, Aline Pereira da [UNIFESP]
Data de Publicação: 2018
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=6912682
https://repositorio.unifesp.br/handle/11600/52490
Resumo: Objective: To evaluate the effectiveness and safety of tramadol in the treatment of pain and quality of life of patients with fibromyalgia. Methods: Systematic review of randomized controlled trials conducted according to the methodology of Cocharne Handbook for Systematic Review of Interventions. The searched in the electronic databases was performed in the period of August 2018 and included CENTRAL, MEDLINE, Embase and LILACS. The clinical trial registry databases ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform were also searched. There was no restriction of language or date of publication. Randomized clinical trials comparing tramadol with or without other drugs, such as antidepressants for the treatment of comparator fibromyalgia, placebo, or other drugs administered by any route or therapeutic form, were included. Primary outcomes included pain reduction; quality of life and serious adverse events. The quality of each included study was assessed using the Cochrane bias risk table. The selection, data extraction and bias risk assessment of the included studies were independently performed by two reviewers. The quality of the evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As a summary measure of effect size estimation, the mean difference (DM) with a 95% confidence interval (CI 95%) for continuous data and for the dichotomous data was calculated, the relative risk (RR) was calculated with a range of confidence intervals (95% CI). Results: Four studies (459 participants) comparing tramadol with or without other drugs for the treatment of fibromyalgia pain were included. Three studies that showed tramadol compared to other drugs or placebo were included for quantitative analysis: I) pain reduction by the Visual AnalogueEVA scale (DM 12.61, 95% CI 16.85, 8.36, 447 patients, P = 0 , 00001, low quality of evidence); II) pain reduction by tender points (DM0.93, 1.82, 0.04, 382 patients, P = 0.04, low quality of evidence); III) improvement in the quality of life through the Fibromyalgia Impact QuestionnaireFIQ (DM 5.48, 95% CI 8.73, 2.24, 382 patients, P = 0.0009, low quality of evidence) and IV) adverse events 1.60, 95% CI 1.07, 2.39, 382 patients, P = 0.02 very low quality of evidence, due to inconsistency). A qualitative synthesis of the outcomes was performed: depression and sleep quality. Conclusions: The use of tramadol alone or in combination with other drugs seems to be effective in relieving pain and improving the quality of life of patients with fibromyalgia. The evidences found were low and very low quality. There is insufficient evidence to determine the safety of tramadol in relation to other drugs. More studies aiming at analgesia, safety and quality of life are necessary.
id UFSP_a7f3b6454c2921128b7ff07179932134
oai_identifier_str oai:repositorio.unifesp.br/:11600/52490
network_acronym_str UFSP
network_name_str Repositório Institucional da UNIFESP
repository_id_str 3465
spelling Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literaturaEffectiveness and safety of the tramadol in the treatment of patients with fribromyalgia: systematic reviewPainTramadolQuality of lifeFibromyalgiaSystematic reviewDorTramadolQualidade de vidaFibromialgiaRevisão sistemáticaObjective: To evaluate the effectiveness and safety of tramadol in the treatment of pain and quality of life of patients with fibromyalgia. Methods: Systematic review of randomized controlled trials conducted according to the methodology of Cocharne Handbook for Systematic Review of Interventions. The searched in the electronic databases was performed in the period of August 2018 and included CENTRAL, MEDLINE, Embase and LILACS. The clinical trial registry databases ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform were also searched. There was no restriction of language or date of publication. Randomized clinical trials comparing tramadol with or without other drugs, such as antidepressants for the treatment of comparator fibromyalgia, placebo, or other drugs administered by any route or therapeutic form, were included. Primary outcomes included pain reduction; quality of life and serious adverse events. The quality of each included study was assessed using the Cochrane bias risk table. The selection, data extraction and bias risk assessment of the included studies were independently performed by two reviewers. The quality of the evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As a summary measure of effect size estimation, the mean difference (DM) with a 95% confidence interval (CI 95%) for continuous data and for the dichotomous data was calculated, the relative risk (RR) was calculated with a range of confidence intervals (95% CI). Results: Four studies (459 participants) comparing tramadol with or without other drugs for the treatment of fibromyalgia pain were included. Three studies that showed tramadol compared to other drugs or placebo were included for quantitative analysis: I) pain reduction by the Visual AnalogueEVA scale (DM 12.61, 95% CI 16.85, 8.36, 447 patients, P = 0 , 00001, low quality of evidence); II) pain reduction by tender points (DM0.93, 1.82, 0.04, 382 patients, P = 0.04, low quality of evidence); III) improvement in the quality of life through the Fibromyalgia Impact QuestionnaireFIQ (DM 5.48, 95% CI 8.73, 2.24, 382 patients, P = 0.0009, low quality of evidence) and IV) adverse events 1.60, 95% CI 1.07, 2.39, 382 patients, P = 0.02 very low quality of evidence, due to inconsistency). A qualitative synthesis of the outcomes was performed: depression and sleep quality. Conclusions: The use of tramadol alone or in combination with other drugs seems to be effective in relieving pain and improving the quality of life of patients with fibromyalgia. The evidences found were low and very low quality. There is insufficient evidence to determine the safety of tramadol in relation to other drugs. More studies aiming at analgesia, safety and quality of life are necessary.Objetivo: Avaliar a efetividade e segurança do tramadol no tratamento da dor e qualidade de vida dos pacientes com fibromialgia. Métodos: Revisão sistemática de ensaios clínicos randomizados realizada segundo a metodologia do Cochrane Handbook for Systematic Reviews of Interventions. A pesquisa nas bases de dados eletrônicas foi realizada no período de agosto de 2018 e incluíram CENTRAL, MEDLINE, Embase e LILACS. As bases de registros de ensaios clínicos ClinicalTrials.gov e World Health Organization International Clinical Trials Registry Platform também foram pesquisadas. Não houve restrição de idioma ou data de publicação. Foram incluídos ensaios clínicos randomizados que compararam o tramadol associado ou não a outras drogas, como por exemplo, antidepressivos para o tratamento da dor na fibromialgia com comparador, placebo ou outras drogas administradas por qualquer via ou forma terapêutica. Os desfechos primários incluíram redução da dor; qualidade de vida e eventos adversos graves. A qualidade de cada estudo incluído foi avaliada por meio da tabela de risco de viés da Cochrane. A seleção, a extração dos dados e a avaliação do risco de viés dos estudos incluídos foram realizadas por dois revisores, de forma independente. A qualidade da evidência foi avaliada pelo Grading of Recommendations Assessment, Development and Evaluation (GRADE). Como medida resumo da estimativa de tamanho do efeito, foi calculada a diferença média (DM) com intervalo de confiança de 95% (IC 95%) para dados contínuos e para os dados dicotômicos, foi calculado o risco relativo (RR) com intervalo de confiança de 95% (IC 95%).Resultados: Foram incluídos quatro estudos (459 participantes) que compararam o tramadol associado ou não a outras drogas para o tratamento da dor na fibromialgia. Foram incluídos para análise quantitativa 3 estudos que demonstraram no grupo tramadol comparado a outras drogas ou placebo: I)redução da dor pela Escala Visual AnalógicaEVA (DM 12.61, IC 95% 16.85, 8.36, 447 pacientes, P= 0,00001, baixa qualidade da evidência); II) redução da dor pelo tender points (DM0.93, 1.82, 0,04, 382 pacientes, P=0.04, baixa qualidade da evidência); III) melhora da qualidade de vida pelo Questionário de Impacto de FibromialgiaFIQ (DM 5.48, IC 95% 8.73, 2.24, 382 pacientes, P=0,0009, baixa qualidade da evidência) e IV) eventos adversos (RR 1.60, IC 95% 1.07, 2.39, 382 pacientes, P=0,02 qualidade da evidência muito baixa). Foi realizada síntese qualitativa dos desfechos: depressão e qualidade do sono. Conclusões: O uso do tramadol isolado ou em combinações com outras drogas parece ser efetivo no alívio da dor e melhora da qualidade de vida dos pacientes com fibromialgia. As evidências encontradas foram de baixa e muito baixa qualidade. Não há evidências suficientes para determinar a segurança do tramadol em relação a outras drogas. Mais estudos visando à analgesia, segurança e qualidade de vida é necessário.Dados abertos - Sucupira - Teses e dissertações (2018)Universidade Federal de São Paulo (UNIFESP)Trevisani, Virginia Fernandes Moca [UNIFESP]Mizzaci, Carolina Christianinihttp://lattes.cnpq.br/2567303884901444http://lattes.cnpq.br/6724987121414198http://lattes.cnpq.br/9054730236021091http://lattes.cnpq.br/3015343657248894Universidade Federal de São Paulo (UNIFESP)Rocha, Aline Pereira da [UNIFESP]2020-03-25T11:43:57Z2020-03-25T11:43:57Z2018-11-28info:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/publishedVersion92 f.application/pdfhttps://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=69126822018-0431.pdfhttps://repositorio.unifesp.br/handle/11600/52490porSão Pauloinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-08-02T16:13:28Zoai:repositorio.unifesp.br/:11600/52490Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-08-02T16:13:28Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
Effectiveness and safety of the tramadol in the treatment of patients with fribromyalgia: systematic review
title Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
spellingShingle Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
Rocha, Aline Pereira da [UNIFESP]
Pain
Tramadol
Quality of life
Fibromyalgia
Systematic review
Dor
Tramadol
Qualidade de vida
Fibromialgia
Revisão sistemática
title_short Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
title_full Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
title_fullStr Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
title_full_unstemmed Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
title_sort Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
author Rocha, Aline Pereira da [UNIFESP]
author_facet Rocha, Aline Pereira da [UNIFESP]
author_role author
dc.contributor.none.fl_str_mv Trevisani, Virginia Fernandes Moca [UNIFESP]
Mizzaci, Carolina Christianini
http://lattes.cnpq.br/2567303884901444
http://lattes.cnpq.br/6724987121414198
http://lattes.cnpq.br/9054730236021091
http://lattes.cnpq.br/3015343657248894
Universidade Federal de São Paulo (UNIFESP)
dc.contributor.author.fl_str_mv Rocha, Aline Pereira da [UNIFESP]
dc.subject.por.fl_str_mv Pain
Tramadol
Quality of life
Fibromyalgia
Systematic review
Dor
Tramadol
Qualidade de vida
Fibromialgia
Revisão sistemática
topic Pain
Tramadol
Quality of life
Fibromyalgia
Systematic review
Dor
Tramadol
Qualidade de vida
Fibromialgia
Revisão sistemática
description Objective: To evaluate the effectiveness and safety of tramadol in the treatment of pain and quality of life of patients with fibromyalgia. Methods: Systematic review of randomized controlled trials conducted according to the methodology of Cocharne Handbook for Systematic Review of Interventions. The searched in the electronic databases was performed in the period of August 2018 and included CENTRAL, MEDLINE, Embase and LILACS. The clinical trial registry databases ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform were also searched. There was no restriction of language or date of publication. Randomized clinical trials comparing tramadol with or without other drugs, such as antidepressants for the treatment of comparator fibromyalgia, placebo, or other drugs administered by any route or therapeutic form, were included. Primary outcomes included pain reduction; quality of life and serious adverse events. The quality of each included study was assessed using the Cochrane bias risk table. The selection, data extraction and bias risk assessment of the included studies were independently performed by two reviewers. The quality of the evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As a summary measure of effect size estimation, the mean difference (DM) with a 95% confidence interval (CI 95%) for continuous data and for the dichotomous data was calculated, the relative risk (RR) was calculated with a range of confidence intervals (95% CI). Results: Four studies (459 participants) comparing tramadol with or without other drugs for the treatment of fibromyalgia pain were included. Three studies that showed tramadol compared to other drugs or placebo were included for quantitative analysis: I) pain reduction by the Visual AnalogueEVA scale (DM 12.61, 95% CI 16.85, 8.36, 447 patients, P = 0 , 00001, low quality of evidence); II) pain reduction by tender points (DM0.93, 1.82, 0.04, 382 patients, P = 0.04, low quality of evidence); III) improvement in the quality of life through the Fibromyalgia Impact QuestionnaireFIQ (DM 5.48, 95% CI 8.73, 2.24, 382 patients, P = 0.0009, low quality of evidence) and IV) adverse events 1.60, 95% CI 1.07, 2.39, 382 patients, P = 0.02 very low quality of evidence, due to inconsistency). A qualitative synthesis of the outcomes was performed: depression and sleep quality. Conclusions: The use of tramadol alone or in combination with other drugs seems to be effective in relieving pain and improving the quality of life of patients with fibromyalgia. The evidences found were low and very low quality. There is insufficient evidence to determine the safety of tramadol in relation to other drugs. More studies aiming at analgesia, safety and quality of life are necessary.
publishDate 2018
dc.date.none.fl_str_mv 2018-11-28
2020-03-25T11:43:57Z
2020-03-25T11:43:57Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format masterThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=6912682
2018-0431.pdf
https://repositorio.unifesp.br/handle/11600/52490
url https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=6912682
https://repositorio.unifesp.br/handle/11600/52490
identifier_str_mv 2018-0431.pdf
dc.language.iso.fl_str_mv por
language por
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 92 f.
application/pdf
dc.coverage.none.fl_str_mv São Paulo
dc.publisher.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
publisher.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
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)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
_version_ 1814268316304277504