RCT | Prophylactic antibiotics show no statistically significant survival improvement in severe alcohol-related hepatitis

Summary: This multicenter, randomized, double-blind clinical trial aimed to determine the efficacy of amoxicillin-clavulanate combined with prednisolone compared to placebo combined with prednisolone on mortality in patients hospitalized with severe alcohol-related hepatitis. The study involved 284 patients from 25 centers in France and Belgium with biopsy-proven severe alcohol-related hepatitis, who were followed up for 180 days.

The primary outcome was all-cause mortality at 60 days, while secondary outcomes included mortality at 90 and 180 days, infection rates, hepatorenal syndrome, and changes in Model for End-stage Liver Disease (MELD) and Lille scores. The results showed no statistically significant difference in 60-day mortality between the two groups, with 17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group. However, infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group compared to the placebo group.

It is worth noting that the study may have been underpowered, as the absolute risk difference of 4% did not achieve statistical significance. In conclusion, the combination of amoxicillin-clavulanate and prednisolone did not show a statistically significant improvement in 2-month survival in patients hospitalized with severe alcohol-related hepatitis compared to prednisolone alone. These findings do not support the use of prophylactic antibiotics to improve survival in this patient population, but the potential underpowered nature of the study should be considered.

Article: Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Commentary on Twitter

Among patients with severe alcohol-related #hepatitis receiving prednisolone, amoxicillin-clavulanate did not improve survival at 60-day follow-up compared with placebo. https://t.co/4XkVL2CTsP #DDW pic.twitter.com/9sh5vennkK

— JAMA (@JAMA_current) May 9, 2023