Efetividade e segurança do tramadol no tratamento dos pacientes com fibromialgia: revisão sistemática da literatura
Autor(a) principal: | |
---|---|
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 |