Prophylactic Antibiotics for Cirrhotics with Upper GI Bleed

22 for mortality

Benefits in NNT

1 in 22 were helped (life saved)
1 in 4 were helped (infection prevented)
77% saw no benefit
4.7% were helped by preventing death
23% were helped by preventing infection

Harms in NNT

An unknown number were harmed (medication effects)
An unknown number were harmed by medication effects
View As:

Efficacy Endpoints

Mortality, infection during hospitalization (spontaneous peritoneal peritonitis, bacteremia, pneumonia, urinary tract infection)

Harm Endpoints

Not Reported


Cirrhotic patients often develop bleeding from gastric or esophageal varices that occur secondary to portal hypertension. Gastrointestinal (GI) bleeding is fatal in approximately 20% of these episodes and bacterial infections are an important contributor to this mortality. Patients with cirrhosis are also known to have impaired immune function and increased translocation of bacteria from the gut into the bloodstream, thus the administration of prophylactic antibiotics during the bleeding event has been proposed as a treatment to help prevent such infections.

This Cochrane Review includes 12 trials (n = 1241) involving cirrhotic patients with upper GI bleeding. Of the 12 included trials, only 1 was placebo controlled, the other 11 examined antibiotics vs. no intervention. These trials demonstrated a clear decrease in overall rate of bacterial infections, with marked reductions in bacteremia, pneumonia, spontaneous bacterial peritonitis and urinary tract infections. With the exception of pneumonia, all of the infections were confirmed by cultures. The trials also noted an overall decrease in mortality. The choice of antibiotic regimen appeared to have no effect, although all antibiotics used in these trials were all chosen because of their activity against gram negative organisms (the most common infecting agents for the targeted infection types).


None of the included trials reported on harms or adverse effects associated with the administration of antibiotics. Furthermore, only 1 trial was placebo controlled, which introduces a real risk of bias. Perhaps more importantly, as noted by the Cochrane Review authors, the data for decreased mortality in the intervention group was not as compelling as it was for preventing infection. Many of the included trials were not powered to determine a mortality benefit. Furthermore, trial sequential analysis (a statistical tool used to evaluate the strength of results found during meta-analysis) found that the 12 included trials were not enough to come a definitive conclusion about the significance of decrease mortality in patients receiving antibiotics. This indicates that even one large, high quality, methodologically rigorous randomized trial has the potential to trump the results of this review, as it may well generate results that are in disagreement with the results of this review (for all outcomes including infection rates). We would like to see a trial like this performed, and we believe that given the poor quality of existing trial data there is clinical equipoise adequate to perform such a trial. However, given that this review represents the best available data, and given the reported benefits of reducing infection and the possible decrease in mortality, it seems appropriate to recommend this intervention in cirrhotic patients with upper GI bleeding.


Daniel Runde, MD


September 28, 2011