Reviewed by Dr. Michael Oji, NAHAL Consults, Lekki, Lagos, Nigeria
Researchers in France and Belgium conducted a muti-center double blind trial to determine if prophylactic antibiotics given to patients with severe alcohol-related hepatitis will reduce all-cause mortality. Patients were recruited based on pre-defined criteria including Maddrey function score ≥32 and Model for End Stage Liver Disease (MELD) score ≥ 21; all 292 randomized participants received 40mg/d of oral prednisolone for 30 days plus amoxicillin 1g and clavulanate 125mg (randomized group) three times daily or oral prednisolone plus placebo packet of oral suspension three times daily for the placebo group. Patients were followed up at 4weeks, 45days, 60 days, 3 months, and 6 months; Primary outcome was 60-day all-cause mortality while secondary outcomes were six parameters including mortality at 90-day and 180-day follow-up, incidence of infection at 60days follow up and therapeutic responses among others. Results mainly showed that all-cause mortality rates at 60 days were 17.3% (24 of 142) among randomized patients and 21.9% (31 of 142) among patients on placebo. They concluded that for patients -receiving prednisolone for severe alcohol related liver hepatitis; amoxicillin -clavulanate did not change outcome at 60-day follow up when compared to placebo.
Reference:
Louvet A, Labreuche J, Dao T, Thévenot T, Oberti F, Bureau C, Paupard T, Nguyen-Khac E, Minello A, Bernard-Chabert B, Anty R, Wartel F, Carbonell N, Pageaux GP, Hilleret MN, Moirand R, Nahon P, Potey C, Duhamel A, Mathurin P. Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1558-1566. doi: 10.1001/jama.2023.4902. PMID: 37159035; PMCID: PMC10170332.