Background and Aims: Vasoactive agents with endoscopic therapy are used to treat acute variceal bleeding (AVB). There are two main groups of vasoactive agents: terlipressin and vasopressin (T-V), and octreotide and somatostatin (O-S). However, the benefit/harm balance is unclear. Our aim was to assess the efficacy and safety of T-V versus O-S for the management of AVB. Methods: We performed a systematic search for randomized controlled trials (RCTs) in PubMed, Scopus, and CENTRAL. Our main outcomes were mortality and adverse events. Secondary outcomes were bleeding control, rebleeding, blood transfusion, hospital stay. We evaluated the certainty of evidence using GRADE methodology. Results: We included 21 RCTs. The risk of mortality (RR: 1.01; 95%CI: 0.83-1.22), bleeding control (RR: 0.96; 95%CI: 0.91-1.02; I 2 =53%), early rebleeding (RR: 0.91; 95%CI: 0.66-1.24: I 2 =0%), late rebleeding (RR: 0.94; 95 CI: 0.56-1.60; I 2 =0%), blood transfusion (MD: 0.04; 95%CI: -0.31-0.39; I 2 =68%) and hospital stay (MD: -1.06; 95%CI: -2.80-0.69; I 2 =0%) were similar between T-V and O-S groups. Only 15 studies reported adverse events, which were significantly higher in the T-V compared to the O-S group (RR 2.39; 95%CI: 1.58-3.63; I 2 =57%). The certainty of evidence was moderate for the main outcomes, and low or very low for others. Conclusions: In cirrhotic patients with AVB, those treated with T-V had similar mortality risk compared to O-S. However, the use of T-V showed an increased risk of adverse events compared to O-S.
El cálculo de tamaño de muestra es un aspecto esencial del diseño de estudios cuantitativos. Un adecuado tamaño de muestra nos permite determinar cuál es la mínima cantidad de participantes necesarios para probar nuestra hipótesis de interés. De esta manera, podemos reducir costos, maximizar el uso de nuestros recursos de investigación y garantizar la factibilidad del estudio. Contradictoriamente, a pesar de su relevancia muy pocos investigadores dominan esta habilidad. Esta revisión tiene por objeto revisar los conceptos básicos para realizar un cálculo de tamaño de muestra y compartir códigos de Stata y R específicamente diseñados para facilitar estos cálculos.
Objective: We systematically assessed the efficacy of liraglutide in non-diabetic obese adults. Methods: Six databases were searched up to July 2021 for randomized controlled trials (RCTs) assessing liraglutide versus placebo in obese adults. Primary outcomes were body weight and body mass index (BMI). Secondary outcomes were treatment-emergent adverse events (TEAEs), hypoglycemic episodes, HbA1c, and blood pressure. Effect measures were risk ratio (RR) or mean difference (MD) with their confidence interval (95%CI). Random-effects models and inverse variance meta-analyses were used. Quality of evidence was assessed using GRADE. Results: Twelve RCTs (n = 8249) were included. In comparison to placebo, liraglutide reduced body weight (MD −3.35 kg; 95%CI −4.65 to −2.05; p < 0.0001), and BMI (MD −1.45 kg/m2; 95%CI −1.98 to −0.91; p < 0.0001). Liraglutide did not reduce TEAEs (RR 1.08; 95%CI 0.92 to 1.27; p = 0.25), and Hb1Ac (MD −0.76%; 95%CI −2.24 to 0.72; p = 0.31). Furthermore, it did not increase hypoglycemic episodes (RR 2.01; 95%CI 0.37 to 11.02; p = 0.28). Finally, liraglutide reduced systolic blood pressure (MD −3.07 mmHg; 95%CI −3.66 to −2.48; p < 0.0001) and diastolic blood pressure (MD −1.01 mmHg; 95%CI −1.55 to −0.47; p = 0.0003). Seven RCTs had a high risk of bias. Subgroup analyses by length of treatment and doses had effects similar to the overall analyses. Quality of evidence was low or very low for most outcomes. Conclusions: In non-diabetic obese adults, liraglutide reduced body weight, BMI and blood pressure in comparison to placebo. Adverse events, Hb1Ac levels and hypoglycemic episodes were not different than placebo.
Background: Cardiovascular diseases are responsible for the majority of deaths resulting from non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with hypertension and this is a key predictor of severe liver outcomes and an indicator of nonspecific portal fibrosis. Aim: To assess the association between hypertension and NAFLD severity. Methods: We conducted a secondary analysis of data from Peruvian adults with obesity and NAFLD who attended a Peruvian bariatric center. The severity of NAFLD was assessed using the Fatty Liver Inhibition of Progression algorithm / Steatosis, Activity and Fibrosis score. Hypertension was determined by either being recorded in the medical records or if the patient had a systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg. To evaluate the association of interest, we calculated crude and adjusted prevalence ratios (aPR) using Poisson generalized linear models with logarithmic link function and robust variances. For the multivariable models, we adjusted for age, sex, physical activity and smoking. Results: Our study included 234 participants. The prevalence of hypertension was 19.2%, while the prevalence of severe NAFLD was 46.2%. After adjusting for confounders, the prevalence of hypertension was found to be significantly higher in the severe NAFLD group compared to the non-severe group (aPR = 1.33; 95% CI: 1.03-1.74). When stratified by the presence of metabolic syndrome (MetS), the association remained significant only in the group without MetS (aPR = 1.80; 95% CI: 1.05-3.11). Conclusion:We found an association between hypertension and severe NAFLD in adults with obesity, particularly in those without MetS.
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