By Cheryl Lathrop
BOSTON -- November 5, 2010 -- Adding the probiotic VSL#3 to propranolol reduced the hepatic venous pressure gradient (HVPG) in patients with cirrhosis with large varices, according to a study presented here at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
"This novel therapy might provide alternative or adjunct therapy to beta-blockers in the management of patients with portal hypertension," said Nitin Gupta, MD, Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India, on November 1.
For the study, the researchers randomised 87 patients with cirrhosis and portal hypertension with large oesophageal varices (nonbleeders) to receive either propranolol plus placebo (group 1; n = 30); propranolol plus norfloxacin (group 2; n = 27) or propranolol + VSL#3 (group 3; n = 30).
Of these, 75 patients underwent the follow-up hepatic vein pressure gradient (HVPG) measurement, and thus completed the study: group 1 (n = 26), group 2 (n = 24), and group 3 (n = 25).
Propranolol was titrated to achieve a heart rate of 55 bpm or a maximum of 320 mg/day. The researchers studied splanchnic haemodynamics before and after 2 months of either treatment.
The primary endpoint was the change in HVPG compared with baseline; the secondary end point was the number of adverse events with therapy.
Addition of VSL#3 to propranolol synergistically increased the degree of reduction of HVPG in patients with cirrhosis with large varices. Responders were 31% in group 1, 46% in group 2, and 60% in group 3 (P =.046). The fall (comparison of change) in HVPG was 2.1 mm Hg in group 1, 3.3 mm Hg in group 2, and 3.7 mm Hg in group 3.
VSL#3 was well tolerated without significant side effects. The number of patients with adverse events did not differ significantly between the groups.
[Presentation title: Addition of Probiotics to Propranolol Improves Response for Primary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis and Large Esophageal Varices. Abstract 1556]
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