This trial was carried out to assess the value of propranolo for the prevtion of recurrent variceal bleeding in patinets with well-compensated cirrhosis. We also compared porpranolol therapy to long-term injection sclerotherapy. One hundred and eight patients, in whom the orginal variceal hemorrhage stopped spontaneousley (before diagnostic endocopy) and without sclerotherpay or surgical intervention were included. All were pugh grade A or B; 55% had alcoholic cirrohosis. Patients were chosen randomly to receive oral propranolol (in a dosage to reduce resting pulse rate by 25%) or to undergo long-term injection sclerotherapy. In both groups, episodes of repeat bleeding that did not stop spontaneously were managed with sclerotherapy. Patients considered to have failed propranolol therapy were treated with long-term sclerothrapy. Follow -up ranged from 12 to 64 mo. In the propranolol group, 28 (54%) of the 52 patients had repeat bleeding from varices with a total of 57 episodes; 14 received long-term sclerotherapy. In the sclerotherapy group, 25 (45%) of the 56 patients had repeat bleeding, with a total of 40 episodes (P < 0.20). On an intetion-to-treat basis, the risk of bleedings expressed per patient-month of follow-up was similar for the two groups, at 0.05 and 0.037, respectitively. Survival as assessed by cumulative life analysis was also similar, with 55% and 66% alive at 3 yr (p <0.40). Stepwise regression analysis of possible factors prediciting further bleeding in patients taking propranolo selected only two variables — the pretreatment pulse rate and the extent of pulse-rate reduction in response to propranolol.
These data support propranolol as an alternative first-line measure to long-term injection for the management of variceal bleeding. The pretreatment pulse rate and subsequent response to propranolo may provide means of selecting those most likely to benefit. (HEPATOLOGY 1990;11:353–359.)