[Intention to treat and follow up are important in assessing validity of a randomized clinical trial].

In this randomized controlled multicenter trial, we compared endoscopic variceal banding ligation (VBL) with propranolol (PPL) for primary prophylaxis of variceal bleeding. One hundred fifty-two cirrhotic patients with 2 or more esophageal varices (diameter >5 mm) without prior bleeding were randomized to VBL (n=75) or PPL (n=77). The groups were well matched with respect to baseline characteristics (age 56±10 years, alcoholic etiology 51%, Child-Pugh score 7.2±1.8). The mean follow-up was 34±19 months. Data were analyzed on an intention-to-treat basis. Neither bleeding incidence nor mortality differed significantly between the 2 groups. Variceal bleeding occurred in 25% of the VBL group and in 29% of the PPL group. The actuarial risks of bleeding after 2 years were 20% (VBL) and 18% (PPL). Fatal bleeding was observed in 12% (VBL) and 10% (PPL). It was associated with the ligation procedure in 2 patients (2.6%). Overall mortality was 45% (VBL) and 43% (PPL) with the 2year actuarial risks being 28% (VBL) and 22% (PPL). 25% of patients withdrew from PPL treatment, 16% due to side effects. In conclusion, VBL and PPL were similarly effective for primary prophylaxis of variceal bleeding. VBL should be offered to patients who are not candidates for long-term PPL treatment. Unidad de Medicina Basada en Evidencia, Pontificia Universidad Católica de Chile. a Interno de Medicina Revisado por Unidad de Medicina Basada en Evidencia. Rev Méd Chile 2004; 132: 1561-1564 M E D I C I N A B A S A D A E N E V I D E N C I A 1562 CONCLUSIÓN DE LOS REVISORES: La incidencia del primer sangrado variceal y la mortalidad general de pacientes cirróticos con várices esofágicas, es similar si son tratados con ligadura o con propanolol como prevención primaria.