BACKGROUND To evaluate the safety and efficiency of variceal ligation compared with endoscopic sclerotherapy, 88 patients with cirrhosis with recent variceal bleeding were randomized to undergo either treatment. METHODS Sclerotherapy was performed using ethanolamine and polidocanol injection at 1, 2, and 3 weeks and every 3 weeks thereafter. The Stiegmann-Goff device was used for variceal ligation at the same intervals. RESULTS The rate of variceal eradication was the same for both groups, but eradication was accomplished sooner in patients undergoing variceal ligation (5.3+/-1.6 vs. 6.6+/-2.4 endoscopic sessions, p < 0.05) and with fewer complications (19 vs. 6, p < 0.005). The rate of recurrent bleeding was lower in patients treated by ligation (31% vs. 50%, p < 0.05). After eradication, variceal recurrence was more frequent in patients treated by variceal ligation at 1 and 3 years (47% and 92% vs. 23% and 55%, p < 0.01). Portal hypertensive gastropathy was significantly worse in the patients who had variceal ligation (17 patients vs. 6, p < 0.01). Survival and treatment failure were similar in both groups. CONCLUSIONS Variceal ligation was superior to sclerotherapy in terms of the rate of recurrent bleeding and the occurrence of complications but worse with respect to recurrence of varices and the evolution of portal hypertensive gastropathy. Long-term follow-up studies are required to find out whether there are deleterious effects of variceal ligation.