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The sham effect of invasive interventions in chronic coronary syndromes : a systematic review and meta-analysis
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Contexto: doentes com síndromes coronárias crónicas podem ser referenciados para tratamentos invasivos devido à complexidade da doença e/ou devido à refratariedade dos sintomas à terapêutica médica. Apesar das recomendações, estes procedimentos ainda não demonstraram eficácia sintomática, quando comparados com uma intervenção sham em ensaios clínicos randomizados.
Objetivos: avaliar o efeito placebo em doentes com angina classe I a IV de acordo com a Canadian Cardiovascular Society (CCS), angina refratária ou equivalentes anginosos.
Métodos de pesquisa: CENTRAL, MEDLINE ® and PsycINFO em dezembro de 2020.
Critérios de seleção: consideramos para inclusão ensaios clínicos randomizados, publicados, com ocultação e um procedimento placebo, que reportassem os efeitos antes e depois de tratamentos invasivos no grupo de doentes alocado ao procedimento placebo. Como resultados selecionamos o tempo de exercício, a melhoria na classe de angina, o número de episódios de angina e o uso de comprimidos de nitroglicerina por semana e avaliação de qualidade de vida através do Seattle Angina Questionnaire (SAQ).
Resultados: 16 ensaios clínicos foram incluídos, registando 1340 doentes. Os resultados demonstraram um aumento de 7% no tempo de exercício com a intervenção placebo (RC 1.07; 95% CI 1.02 a 1.11; SMD 0.22; 95% CI 0.09 to 0.35) e que a classe de angina (MD -0.78; 95% CI -1.10 to -0.47), episódios de angina (MD -10.29; 95% CI -13.04 to -7.54) e uso de nitroglicerina (MD -3.98; 95% CI -5.14 to -2.82) diminuíram significativamente. A qualidade de vida também demonstrou melhoria nos domínios da limitação física, frequência de angina, satisfação de tratamento e perceção de doença.
Conclusão: Intervenções placebo em doentes com síndromes coronárias crónicas causaram uma diminuição dos episódios de angina, uso de nitroglicerina e classe de angina e um aumento da qualidade de vida. Também demonstraram um pequeno aumento no tempo de exercício.
Background: Patients with chronic coronary syndromes might be referenced to invasive treatments such as revascularization procedure due to the complexity of the disease and/or due to the refractoriness of symptoms to the medical treatment. Despite the recommendations, these procedures have not yet shown a symptomatic efficacy when compared with sham intervention in randomized controlled trials (RCTs). Objectives: Assess the effects of the sham procedure for chronic coronary syndromes in patients with Canadian Cardiovascular Society (CCS) angina class I to IV, refractory angina or angina equivalents. Search methods: We searched in CENTRAL, MEDLINE® and PsycINFO (December 2020). Selection criteria: We considered for inclusion published RCTs, patient-blind with sham procedure, reporting the pre-post effects in invasive sham arm treatment for chronic coronary syndromes. The evaluated outcomes were: exercise time in stress test, improvement in CCS angina class, number of anginal episodes per week, nitroglycerin (NTG) use per week and Quality of Life assessment using the Seattle Angina Questionnaire (SAQ). Main results: 16 RCTs were included, enrolling 1340 patients. Pooled results showed a 7% increase in exercise time with the sham intervention (RC 1.07; 95% CI 1.02 to 1.11; SMD 0.22; 95% CI 0.09 to 0.35) and that CCS class (MD -0.78; 95% CI -1.10 to -0.47), anginal episodes (MD -10.29; 95% CI -13.04 to -7.54) and NTG use (MD -3.98; 95% CI -5.14 to -2.82) were significantly reduced. The quality of life using SAQ scale also improved in the domains of physical limitation (MD 10.67; 95% CI 5.47 to 15.88), angina frequency (MD 17.21; 95% CI 10.48 to 23.94), treatment satisfaction (MD 6.43; 95% CI 2.51 to 10.35) and disease perception (MD 10.98; 95% CI 6.53 to 15.44). Conclusions: Sham interventions in patients with chronic coronary syndromes decreased anginal episodes, NTG use and CCS angina class and increased SAQ quality of life. It also revealed a small change in exercise time.
Background: Patients with chronic coronary syndromes might be referenced to invasive treatments such as revascularization procedure due to the complexity of the disease and/or due to the refractoriness of symptoms to the medical treatment. Despite the recommendations, these procedures have not yet shown a symptomatic efficacy when compared with sham intervention in randomized controlled trials (RCTs). Objectives: Assess the effects of the sham procedure for chronic coronary syndromes in patients with Canadian Cardiovascular Society (CCS) angina class I to IV, refractory angina or angina equivalents. Search methods: We searched in CENTRAL, MEDLINE® and PsycINFO (December 2020). Selection criteria: We considered for inclusion published RCTs, patient-blind with sham procedure, reporting the pre-post effects in invasive sham arm treatment for chronic coronary syndromes. The evaluated outcomes were: exercise time in stress test, improvement in CCS angina class, number of anginal episodes per week, nitroglycerin (NTG) use per week and Quality of Life assessment using the Seattle Angina Questionnaire (SAQ). Main results: 16 RCTs were included, enrolling 1340 patients. Pooled results showed a 7% increase in exercise time with the sham intervention (RC 1.07; 95% CI 1.02 to 1.11; SMD 0.22; 95% CI 0.09 to 0.35) and that CCS class (MD -0.78; 95% CI -1.10 to -0.47), anginal episodes (MD -10.29; 95% CI -13.04 to -7.54) and NTG use (MD -3.98; 95% CI -5.14 to -2.82) were significantly reduced. The quality of life using SAQ scale also improved in the domains of physical limitation (MD 10.67; 95% CI 5.47 to 15.88), angina frequency (MD 17.21; 95% CI 10.48 to 23.94), treatment satisfaction (MD 6.43; 95% CI 2.51 to 10.35) and disease perception (MD 10.98; 95% CI 6.53 to 15.44). Conclusions: Sham interventions in patients with chronic coronary syndromes decreased anginal episodes, NTG use and CCS angina class and increased SAQ quality of life. It also revealed a small change in exercise time.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2021
Palavras-chave
Síndrome coronária crónica Efeito placebo Procedimento invasivo