Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
In the specific setting of the evaluation of corticosteroids, pentoxifylline of their
combination in severe alcoholic hepatitis, only meta-analysis combining individual data is
able to provide detailed information from each individual with severe alcoholic hepatitis
assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both
univariate and multivariate analyses, truth survival is lower for conclusions from
meta-analysis of the literature than for conclusions derived from non-meta-analyses.
The present study is a meta-analysis of individual data from RCTs restricted to patients with
a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving
either corticosteroids, or pentoxifylline or their combination to those of patients not
receiving them adjusted on the independent prognostic factors at baseline.
The secondary endpoints will be: a) assessment of response to the assigned treatment using
the Lille model; b) analysis of 6-month survival according to allocated therapy.