Reuters Health Information (2010-07-08): Propranolol, ligation equally effective against variceal bleeding without cirrhosis
Propranolol, ligation equally effective against variceal bleeding without cirrhosis
Last Updated: 2010-07-08 16:25:06 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Beta-blockers prevent variceal re-bleeding as effectively as endoscopic ligation in patients with non-cirrhotic portal hypertension (NCPH), researchers from India have found.
Their randomized trial was the first head-to-head comparison of beta-blockers versus ligation in this setting. "Our study should be considered practice-changing," senior author Dr. Ashish Kumar of the Institute of Liver & Biliary Sciences told Reuters Health by e-mail.
Until now, he explained, bleeding varices in portal hypertension patients without cirrhosis were managed with band ligation, while patients with cirrhosis received band ligation and beta-blockers. But with this study, Dr. Kumar said, "it has been proved that beta-blockers are effective in non-cirrhotic portal hypertension as well."
As Dr. Kumar and colleagues reported online June 14th in Gastroenterology, they randomly assigned 101 consecutive patients with NCPH plus variceal bleeding in the previous six weeks to be treated approximately every three weeks with either endoscopic variceal ligation or propranolol.
The propranolol dose began at 20 mg twice a day and was increased until the patient achieved a heart rate of 55 bpm, until the maximum dose of 320 mg/day was reached, or until side effects were seen. The median dose was 160 mg/day.
Ninety-four participants were available for evaluation; the others were lost to follow-up and were considered failures.
On intention-to-treat analysis, nine patients on beta blockers (18%) and 12 in the ligation group (23.5%) had rebleeding during a median follow-up of 23 months. In the per-protocol analysis, six propranolol patients (12.7%) and eight ligation patients (17%) rebled. Neither difference was statistically significant.
Similarly, treatment assignment did not affect the risk of rebleeding for the 21 patients who also had portal fibrosis.
Patients in the two treatment groups had rebleeding due to similar causes: five from esophageal varices and one from gastric varices in the propranolol group, and five from esophageal varices, two from gastric varices and one from banding ulcers in the ligation group.
Propranolol reduced the grade of esophageal varices in about half of the patients. Ligation eradicated varices in 84% of patients after a median of three sessions.
Adverse effects were generally minor, and there were no deaths during the study.
"The results...clearly demonstrate that beta blockers are as effective as endoscopic variceal band ligation in the secondary prevention of variceal bleeding in patients with non-cirrhotic portal hypertension," the authors conclude.
A new question, they add, is whether a combination of beta blockers and ligation is superior to either alone.