Lack of effect of propranolol in the prevention of large oesophageal varices in patients with cirrhosis: a randomized trial. French-Speaking Club for the Study of Portal Hypertension.
OBJECTIVE
Beta-blockers have been shown to reduce portal pressure in patients with cirrhosis and limit the development of portosystemic shunts in portal hypertensive animals. Thus, a randomized double-blind trial was conducted to evaluate propranolol in the prevention of the development of large oesophageal varices in patients with cirrhosis without varices or with small varices.


METHODS
One hundred and two patients received long-acting propranolol (160 mg/day) and 104 patients received a placebo. At inclusion, there was no significant difference between the two groups in terms of clinical characteristics or biochemical tests. At 2 years, the size of varices was estimated on video recordings.


RESULTS
One-third of the patients were lost to follow-up, and 95%/97% of the remaining patients were compliant in the propranolol and placebo groups, respectively. At 2 years, the proportion of patients with large varices was 31% in the propranolol group and 14% in the placebo group (P< 0.05). Three and four patients bled in the propranolol and placebo groups, respectively, and nine and ten died, respectively.


CONCLUSIONS
This trial suggests that propranolol administration cannot be recommended for the prevention of the development of large oesophageal varices in patients with cirrhosis; thus other studies are needed in selected subgroups of patients.
Calés
P
P
Department of Hepato-Gastroenterology, University Hospital of Angers, France.
Oberti
F
F
Payen
J L
JL
Naveau
S
S
Guyader
D
D
Blanc
P
P
Abergel
A
A
Bichard
P
P
Raymond
J M
JM
Canva-Delcambre
V
V
Vetter
D
D
Valla
D
D
Beauchant
M
M
Hadengue
A
A
Champigneulle
B
B
Pascal
J P
JP
Poynard
T
T
Lebrec
D
D
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004932:Esophageal and Gastric Varices / Q000150:complications* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011433:Propranolol / Q000627:therapeutic use*; D017211:Treatment Failure
D000319:Adrenergic beta-Antagonists; D011433:Propranolol