Prophylaxis of first hemorrhage from esophageal varices by sclerotherapy, propranolol or both in cirrhotic patients: a randomized multicenter trial. The PROVA Study Group.

The objective of this randomized multicenter trial was to assess the prophylactic effect on the incidence and severity of the first variceal hemorrhage of endoscopic sclerotherapy, propranolol and the combination of the two compared with none of these treatments in patients with cirrhosis and esophageal varices. Among 819 cirrhotic patients who never had experienced variceal bleeding, esophagoscopy revealed varices in 379, of whom 286 were enrolled in the trial; 73 were allocated to sclerotherapy (paravenous polidocanol [10 mg/ml] every 1 to 2 wk until eradication), 68 to propranolol (slow-release preparation in one daily dose adjusted to provide about 25% heart rate reduction), 73 to both treatments and 72 to neither of the two treatments. The patients were observed for up to 42 mo, with an average of 15 mo. After variceal bleeding, patients in all groups received sclerotherapy only. The incidences of variceal bleeding (n = 50) were almost identical in the four groups. The relative risk (with 95% confidence limits) with sclerotherapy was 1.06 (0.61 to 1.84), and the relative risk with propranolol was 0.92 (0.53 to 1.60). The mortality rate after variceal bleeding (n = 29) did not differ significantly either. The mortality rate without variceal bleeding (n = 46) was 2.75 (1.45 to 5.22) times higher in the sclerotherapy groups than in the nonsclerotherapy groups (p = 0.002), whereas propranolol showed no effect, the relative risk being 1.17 (0.66 to 2.10). The total mortality rate showed no significant difference between the sclerotherapy, propranolol and control groups, but the combined therapy group had a significantly increased mortality rate.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes