RESUMO
Fibromyalgia is a debilitating and chronic pain processing disorder, in which the proportion of patients who achieve good results with pharmacotherapy is small. However, choosing the best available evidence on pharmacotherapy can optimize patient clinical outcomes. Objective: This overview aimed to identify in systematic reviews the effects of pharmacotherapy on fibromyalgia, considering the quality of the reviews and the efficacy of the outcomes. Methods: This search was performed in seven databases: PubMed, Web of Science, COCHRANE, Lilacs, Embase, Scopus and IPA. The methodological quality was evaluated using A MeaSurement Tool to Assess Systematic Reviews 2. The protocol was registered in the PROSPERO database (CRD42018095943). Results: A total of 63 systematic reviews were selected after reading full texts, but only 8 of them were of moderate to high quality and were included in this overview. All included reviews were published in English, between 2012 and 2018, performed meta-analysis, used the American College of Rheumatology (1990) diagnostic criteria for fibromyalgia, and jointly assessed pain improvement, adverse reactions, and withdrawal. Most reviews included only randomized controlled trials. Of the fourteen drugs addressed in systematic reviews evaluated, duloxetine, milnacipran, and pregabalin showed evidence of improvement in pain (Moderate: ≤30%) and other fibromyalgia symptoms, as depression and fatigue. However, these medications presented significant withdrawals due to adverse reactions (mainly nausea, headache, dizziness and constipation). The rate of treatment withdrawal reached 36%. Conclusion: Few studies have high quality and sufficient evidence on the effect of medicines on fibromyalgia, resulting in a lack of support for prescribers to choose drugs that meet criteria for need, effectiveness, safety and compliance.
Fibromialgia é um distúrbio de processamento da dor debilitante e crônico, em que a proporção de pacientes que obtêm bons resultados com a farmacoterapia é pequena. No entanto, escolher a melhor evidência disponível sobre a farmacoterapia pode otimizar os resultados clínicos do paciente. Objetivo: Esta overview teve como objetivo identificar em revisões sistemáticas os efeitos da farmacoterapia na fibromialgia, considerando a qualidade das revisões e a eficácia dos resultados. Métodos: Esta busca foi realizada em sete bases de dados: PubMed, Web of Science, COCHRANE, Lilacs, Embase, Scopus e IPA. A qualidade metodológica foi avaliada usando A MeaSurement Tool to Assess Systematic Reviews 2. O protocolo foi registrado no PROSPERO (CRD42018095943). Resultados: Um total de 63 revisões sistemáticas foram selecionadas após a leitura de textos completos, mas apenas 8 delas eram de qualidade moderada a alta e foram incluídas nesta overview. Todas as revisões incluídas foram publicadas em inglês, entre 2012 e 2018, realizaram meta-análises, utilizaram os critérios de diagnósticos do American College of Rheumatology (1990) para fibromialgia e avaliaram conjuntamente a melhora da dor, reações adversas e retiradas. A maioria das revisões incluiu apenas ensaios clínicos randomizados. Dos quatorze medicamentos abordados nas revisões sistemáticas avaliadas, duloxetina, milnaciprano e pregabalina mostraram evidências de melhora da dor (moderada: ≤30%) e de outros sintomas da fibromialgia como depressão e fadiga. No entanto, esses medicamentos apresentaram retiradas significativas devido a reações adversas (principalmente náusea, cefaleia, tontura e constipação). A taxa de abandono ao tratamento chegou a 36%. Conclusão: Poucos estudos apresentam evidências suficientes e de alta qualidade sobre o efeito dos medicamentos na fibromialgia, resultando na falta de apoio para os prescritores escolherem medicamentos que atendam aos critérios de necessidade, eficácia, segurança e adesão.
RESUMO
BACKGROUND: It is often unclear whether systematic reviews and primary studies are de-signed to elucidate the efficacy or effectiveness of interventions. This may compromise the use of the information in clinical or policy decisions. OBJECTIVE: This overview aimed to evaluate the methodological profiles of studies on fibromyalgia pharmacotherapy in terms of the quality and nature of the interventions (efficacy versus effective-ness). METHODS: The protocol was registered in the International Prospective Register of Systematic Re-views database. Seven databases were searched for relevant publications. Systematic reviews inves-tigating the effectiveness or efficacy of fibromyalgia pharmacotherapy were included. Methodolog-ical quality was investigated using A MeaSurement Tool to Assess Systematic Reviews (AM-STAR), and efficacy andeffectiveness were evaluated using Rating of Included Trials on the Effica-cy-effectiveness Spectrum (RITES). RESULTS: In this overview, 4,107 studies were initially identified. 8 systematic reviews and 34 prima-ry studies remained after overlaps were removed. Of the eight systematic reviews, 4.76% (n=3) and 7.93% (n=5) were of moderate and high quality, respectively. An analysis of systematic reviews clearly showed the criteria "participants characteristics" and "trial setting" with the most frequent answers as scales 1 and 2 (strong emphasis on efficacy or rather strong emphasis on efficacy), re-spectively. RITES analysis revealed that the most frequent response was "strong emphasis on effi-cacy" in 68% (92/136) of primary studies. CONCLUSION: This analysis showed, in both systematic reviews and primary studies, a predominantly strong emphasis on efficacy, suggesting the need for methodological quality improvement in future studies, especially those designed to provide evidence related to effectiveness. The protocol for this overview has been registered in the International Prospective Register of Sys-tematic Reviews (PROSPERO; CRD42018095943).
