title: Effects of the adjunctive probiotic VSL#3 on portal haemodynamics in patients with cirrhosis and large varices: a randomized trial.
abstract: BACKGROUND
  Probiotics, by altering gut flora, may favourably alter portal haemodynamics in patients with cirrhosis.
  
  
  OBJECTIVE
  To investigate the effect of probiotics on portal pressure in patients with cirrhosis.
  
  
  METHODS
  Randomized double-blind placebo-controlled trial conducted in G.B. Pant Hospital, New Delhi. A total of 94 cirrhotic patients having large oesophageal varices without history of variceal bleeding were randomized to three treatment groups and given 2 months' treatment with propranolol plus placebo, propranolol plus antibiotics (norfloxacin 400 mg BD) or propranolol plus probiotic (VSL#3, 900 billion/day) randomly assigned in 1:1:1 ratio. Outcome measures were change in Hepatic venous pressure gradient (HVPG): Response rate (Percentage of patients having a decrease from baseline of ≥20% or to ≤12 mm Hg) and changes from baseline; biochemical markers of inflammation: changes from baseline.
  
  
  RESULTS
  Adjunctive probiotics increased the response rate compared with propranolol alone (58% vs. 31%, P = 0.046), similar to adjunctive antibiotics (54%). The mean fall in HVPG was greater with either adjunctive probiotics (3.7 mm Hg vs. 2.1 mm Hg, P = 0.061) or adjunctive antibiotics (3.4 mm Hg) than with propranolol alone. Both adjunctive therapies were associated with greater decreases in TNF-α levels (in both peripheral and hepatic venous blood) that resulted from propranolol-only treatment. No clinically relevant between-group differences were observed in the type or frequency of adverse events.
  
  
  CONCLUSIONS
  Adjunctive probiotic (VSL#3) improved the response rate to propranolol therapy and was safe and well tolerated in patients with cirrhosis. Adjunctive probiotic therapy merits further study for reduction in portal pressure.
authors.affiliation: Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Nitin
authors.initials: N
authors.lastname: Gupta
authors.forename: Ashish
authors.initials: A
authors.lastname: Kumar
authors.forename: Praveen
authors.initials: P
authors.lastname: Sharma
authors.forename: Vishal
authors.initials: V
authors.lastname: Garg
authors.forename: Barjesh C
authors.initials: BC
authors.lastname: Sharma
authors.forename: Shiv K
authors.initials: SK
authors.lastname: Sarin
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004932:Esophageal and Gastric Varices / Q000175:diagnosis / Q000382:microbiology / Q000628:therapy*; D005260:Female; D006439:Hemodynamics; D006801:Humans; D006975:Hypertension, Portal / Q000175:diagnosis / Q000382:microbiology / Q000628:therapy*; D007194:India; D018836:Inflammation Mediators / Q000097:blood; D007422:Intestines / Q000382:microbiology*; D008102:Liver Circulation; D008103:Liver Cirrhosis / Q000150:complications / Q000175:diagnosis / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009643:Norfloxacin / Q000627:therapeutic use; D017082:Portal Pressure; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D011433:Propranolol / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood; D014665:Vasodilator Agents / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D015415:Biomarkers; D018836:Inflammation Mediators; D014409:Tumor Necrosis Factor-alpha; D014665:Vasodilator Agents; D011433:Propranolol; D009643:Norfloxacin
keywords: HVPG; portal hypertension; portal pressure; primary prophylaxis; probiotics; variceal bleed