title: Ligation versus propranolol for the primary prophylaxis of variceal bleeding in cirrhosis.
abstract: 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 2-year 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.
authors.affiliation: Department of Internal Medicine I, University of Bonn, Bonn, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schepke
authors.forename: Gerhard
authors.initials: G
authors.lastname: Kleber
authors.forename: Dieter
authors.initials: D
authors.lastname: Nürnberg
authors.forename: Jörg
authors.initials: J
authors.lastname: Willert
authors.forename: Lydia
authors.initials: L
authors.lastname: Koch
authors.forename: Wilfried
authors.initials: W
authors.lastname: Veltzke-Schlieker
authors.forename: Claus
authors.initials: C
authors.lastname: Hellerbrand
authors.forename: Johannes
authors.initials: J
authors.lastname: Kuth
authors.forename: Stefan
authors.initials: S
authors.lastname: Schanz
authors.forename: Stefan
authors.initials: S
authors.lastname: Kahl
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Fleig
authors.forename: Tilman
authors.initials: T
authors.lastname: Sauerbruch
mesh_terms: D000206:Actuarial Analysis; D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004932:Esophageal and Gastric Varices / Q000150:complications / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*; D004947:Esophagus / Q000601:surgery*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008026:Ligation / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011433:Propranolol / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D011433:Propranolol