Prophylaxis of first hemorrhage from esophageal varices by sclerotherapy, propranolol or both in cirrhotic patients: A randomized multicenter trial
1991

Prophylaxis of First Hemorrhage from Esophageal Varices

Sample size: 286 publication Evidence: moderate

Author Information

Author(s): PROVA Study Group

Hypothesis

Does endoscopic sclerotherapy, propranolol, or both effectively prevent the first variceal hemorrhage in cirrhotic patients?

Conclusion

The study found no significant benefit of sclerotherapy or propranolol in preventing variceal bleeding in cirrhotic patients.

Supporting Evidence

  • Variceal bleeding occurred in a similar proportion in all groups.
  • The mortality rate without variceal bleeding was significantly higher in the sclerotherapy groups.
  • The total mortality rate showed no significant difference between treatment groups.

Takeaway

Doctors tested if certain treatments could stop bleeding in patients with liver problems, but they found that these treatments didn't help.

Methodology

Randomized multicenter trial comparing sclerotherapy, propranolol, both, and a control group in cirrhotic patients with esophageal varices.

Potential Biases

Potential bias in bleeding definitions and treatment allocation.

Limitations

The trial was stopped early due to excess mortality in the sclerotherapy group.

Participant Demographics

Cirrhotic patients with esophageal varices, 819 screened, 286 enrolled.

Statistical Information

P-Value

0.002

Confidence Interval

1.45 to 5.22

Statistical Significance

p<0.002

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