Análise da segurança e da efetividade do balão intragástrico em pacientes com obesidade
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Data
2007
Autores
Fernandes, Marcos Aparecido [UNIFESP]
Orientadores
Matos, Delcio [UNIFESP]
Tipo
Tese de doutorado
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ISSN da Revista
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Contexto: a idéia de sucesso no tratamento da obesidade tem sido profundamente influenciada por evidencias de que perdas pequenas de peso podem propiciar ganhos significativos para a saúde. Uma opção terapêutica consiste na colocação de um balão intragástrico de silicone, desenvolvido como um tratamento adjuvante paliativo. Entretanto parecem controversos os resultados comparativos entre os diferentes procedimentos associados ao balão intragástrico e os diferentes tratamentos convencionais. Objetivo: avaliar a segurança e a efetividade do balão intragástrico em pacientes com obesidade. Métodos: revisão sistemática de ensaios clínicos randômicos com metanálise. Os bancos de dados utilizados para a identificação dos estudos foram: EMBASE, LILACS, MEDLlNE, registro de ensaios clínicos da COLABORACAO COCHRANE, lista de referencias bibliogn3ficas e comunicação pessoal. Os critérios de inclusão estabeleciam pacientes com sobrepeso (IMC 25-29,9 kg/m2), grau I de obesidade (IMC 30-34,9 kg/m2), grau "(IMC 35-39,9 kg/m2), grau 1/1 (IMC acima de 40 kglm2) e pacientes superobesos (IMC acima de 50 kg/m2) submetidos as seguintes intervenções: balão intragástrico versus terapia dietética, balão intragástrico versus ausência de tratamento, balão intragástrico versus balão intragástrico e terapia dietética, balão intragástrico e terapia dietética versus terapia dietética somente. Os desfechos clínicos estudados foram: perda de peso (kg) ou outras medidas antropométricos, efeitos adversos, qualidade de vida, mortalidade, índices de revisão, complicações, co-morbidade e custos. Resultados: balão intragástrico versus dieta - a dieta demonstrou ser mais efetiva (p<0,00001), porem com heterogeneidade estatística (p=O,002 e 12=89,5%) com [WMD 3.49 (95% IC, 2.75, 4.23)]. Balão intragástrico versus ausência de tratamento - urn único estudo apresentou resultado mais efetivo a favor do grupo tratado com balão intragástrico (p<0,00001) com [WMD - 3.80 (95% IC, - 4.23, ¬3.37)]. Balão intragástrico versus balão intragástrico e dieta - urn único estudo demonstrou que a associação do balão intragástrico com a dieta foi mais efetiva em induzir perda de peso (p<0,00001) com [WMD 1.90 (95% IC, 1.33, 2.47)]. Balão intrag8strico e dieta versus somente dieta - dados de cinco estudos não demonstraram diferença estatisticamente significante (p=0,83), porem com heterogeneidade estatística (p<0,00001 e 12=91,7%) com [WMD - 0.04 (95% IC, -0.44, 0.35»). complicações menores: ulceras gástricas - em seis estudos, a incidência de ulcera g8strica foi superior no grupo de pacientes submetidos ao balão intragástrico (p=0,006) ....(au).
Context: The idea of success in treating obesity has been profoundly influenced by evidence that small weight losses may produce significant gains in health. One option is to place a silicone balloon inside the stomach, which has been developed as palliative adjuvant treatment. However, the comparative results between the different procedures associated with intragastric balloons and between the different conventional treatments seem uncertain. Objective: To evaluate the safety and effectiveness of intragastric balloons in obese patients. Methods: Systematic review of randomized clinical trials with meta-analysis. The databases used for identifying studies were: EMBASE, LILACS, MEDLINE, Cochrane Collaboration register of clinical trials, bibliographic reference lists and personal communication. The inclusion criteria were overweight patients (BMI 25-29.9 kg/m²), patients with grade I obesity (BMI 30-34.9 kg/m²), grade II (BMI 35-39.9 kg/m²) and grade III (BMI greater than 40 kg/m²) and super-obese patients (BMI greater than 50 kg/m²) submitted for these interventions: Intragastric balloon versus dietary therapy; Intragastric balloon versus no treatment; Intragastric balloon versus intragastric balloon and dietary therapy; Intragastric balloon and dietary therapy versus dietary therapy alone. The outcomes measurements were: weight loss (kg) or other anthropometric measurements, adverse effects, quality of life, mortality, revision rates, complications, comorbidities and costs. Results: Intragastric balloon versus diet: Diet was shown to be more effective (p<0.00001), however with statistical heterogeneity (p=0.002 e I²=89.5%) with [WMD 3.49 (95% CI: 2.75, 4.23)]. Intragastric balloon versus no treatment: A single study presented a more effective result in favor of the group treated with intragastric balloon (p<0.00001) with [WMD - 3.80 (95% CI: - 4.23, - 3.37)]. Intragastric balloon versus intragastric balloon and diet: A single study showed that the association of intragastric balloon with diet was more effective in inducing weight loss (p<0.00001) with [WMD 1.90 (95% CI: 1.33, 2.47)]. Intragastric balloon and diet versus diet alone: Data from five studies did not show a difference statistically significant (p=0.83), however with statistical heterogeneity (p<0.00001 e I²=91.7%) with [WMD - 0.04 (95% CI: -0.44, 0.35)]. Minor complications: Gastric ulcers: In six studies the incidence of gastric ulcers was greater in the group of patients who had the intragastric balloon (p=0.006) and heterogeneity test with (p=0.88 e I²=0%). The number needed to cause harm (NNH) was 17:1. Gastric erosion: In six studies there was greater incidence of gastric erosion among patients in the group with the intragastric balloon (p<0.00001), and heterogeneity test with (p=0.66 e I²=0%). The number needed to cause harm (NNH) was 6:1. Abdominal pain: Data from four studies showed greater incidence of abdominal pain among patients in the group with the intragastric balloon with statistical significance (p=0.0002) and heterogeneity test with (p=0.52 e I²=0%). Vomiting: Data from two studies showed any statistical significant difference (p=0.09) and heterogeneity test with (p=0.79 e I²=0%). Major complications: Deflation and migration of the intragastric balloon: Two studies showed any statistical significant difference (p=0.38) and heterogeneity test with (p=0.92 e I²=0%). Obstruction of the small intestine: A single study did not show statistical difference (p=0.20) with [RR 7.00 (95% CI: 037, 133.60)]. Mallory-Weiss: One study included showed any statistical significant difference (p=0.03) with [RR 21.00 (95% CI: 1.25, 353.06)]. Esophageal laceration: A single study did not show statistical difference (p=0.50) with [RR 3.00 (95% CI: 0.12, 72.68)]. Conclusion: On the basis of the result from this systematic review and meta-analysis, we can conclude that there is no scientific evidence available that would demonstrate effectiveness of an intragastric balloon as temporary adjuvant treatment for obesity when compared with conventional dietary therapy for weight loss. Comparison of the safety of this method has defined that the intragastric balloon in itself and the technique for positioning it are safe.
Context: The idea of success in treating obesity has been profoundly influenced by evidence that small weight losses may produce significant gains in health. One option is to place a silicone balloon inside the stomach, which has been developed as palliative adjuvant treatment. However, the comparative results between the different procedures associated with intragastric balloons and between the different conventional treatments seem uncertain. Objective: To evaluate the safety and effectiveness of intragastric balloons in obese patients. Methods: Systematic review of randomized clinical trials with meta-analysis. The databases used for identifying studies were: EMBASE, LILACS, MEDLINE, Cochrane Collaboration register of clinical trials, bibliographic reference lists and personal communication. The inclusion criteria were overweight patients (BMI 25-29.9 kg/m²), patients with grade I obesity (BMI 30-34.9 kg/m²), grade II (BMI 35-39.9 kg/m²) and grade III (BMI greater than 40 kg/m²) and super-obese patients (BMI greater than 50 kg/m²) submitted for these interventions: Intragastric balloon versus dietary therapy; Intragastric balloon versus no treatment; Intragastric balloon versus intragastric balloon and dietary therapy; Intragastric balloon and dietary therapy versus dietary therapy alone. The outcomes measurements were: weight loss (kg) or other anthropometric measurements, adverse effects, quality of life, mortality, revision rates, complications, comorbidities and costs. Results: Intragastric balloon versus diet: Diet was shown to be more effective (p<0.00001), however with statistical heterogeneity (p=0.002 e I²=89.5%) with [WMD 3.49 (95% CI: 2.75, 4.23)]. Intragastric balloon versus no treatment: A single study presented a more effective result in favor of the group treated with intragastric balloon (p<0.00001) with [WMD - 3.80 (95% CI: - 4.23, - 3.37)]. Intragastric balloon versus intragastric balloon and diet: A single study showed that the association of intragastric balloon with diet was more effective in inducing weight loss (p<0.00001) with [WMD 1.90 (95% CI: 1.33, 2.47)]. Intragastric balloon and diet versus diet alone: Data from five studies did not show a difference statistically significant (p=0.83), however with statistical heterogeneity (p<0.00001 e I²=91.7%) with [WMD - 0.04 (95% CI: -0.44, 0.35)]. Minor complications: Gastric ulcers: In six studies the incidence of gastric ulcers was greater in the group of patients who had the intragastric balloon (p=0.006) and heterogeneity test with (p=0.88 e I²=0%). The number needed to cause harm (NNH) was 17:1. Gastric erosion: In six studies there was greater incidence of gastric erosion among patients in the group with the intragastric balloon (p<0.00001), and heterogeneity test with (p=0.66 e I²=0%). The number needed to cause harm (NNH) was 6:1. Abdominal pain: Data from four studies showed greater incidence of abdominal pain among patients in the group with the intragastric balloon with statistical significance (p=0.0002) and heterogeneity test with (p=0.52 e I²=0%). Vomiting: Data from two studies showed any statistical significant difference (p=0.09) and heterogeneity test with (p=0.79 e I²=0%). Major complications: Deflation and migration of the intragastric balloon: Two studies showed any statistical significant difference (p=0.38) and heterogeneity test with (p=0.92 e I²=0%). Obstruction of the small intestine: A single study did not show statistical difference (p=0.20) with [RR 7.00 (95% CI: 037, 133.60)]. Mallory-Weiss: One study included showed any statistical significant difference (p=0.03) with [RR 21.00 (95% CI: 1.25, 353.06)]. Esophageal laceration: A single study did not show statistical difference (p=0.50) with [RR 3.00 (95% CI: 0.12, 72.68)]. Conclusion: On the basis of the result from this systematic review and meta-analysis, we can conclude that there is no scientific evidence available that would demonstrate effectiveness of an intragastric balloon as temporary adjuvant treatment for obesity when compared with conventional dietary therapy for weight loss. Comparison of the safety of this method has defined that the intragastric balloon in itself and the technique for positioning it are safe.
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Citação
São Paulo: [s.n.], 2007. 133 p.