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

• Ano de defesa: 2018
• Autor(a) principal: Rocha, Aline Pereira da [UNIFESP]
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de São Paulo (UNIFESP)
• Palavras-chave em Português: Pain; Tramadol; Quality of life; Fibromyalgia; Systematic review; Dor; Qualidade de vida; Fibromialgia; Revisão sistemática
• Link de acesso: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=6912682; https://repositorio.unifesp.br/handle/11600/52490

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.