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Treatment of severe alcoholic hepatitis by infusion of insulin and glucagon: A multicenter sequential trial
Author(s) -
Trinchet JeanClaude,
Balkau Beverley,
Poupon Renée E.,
Heintzmann François,
Callard Patrice,
Gotheil Cécile,
Grange JeanDidier,
Vetter Denis,
Pauwels Arnaud,
Labadie Hélène,
Chazouilleres Olivier,
Mavier Philippe,
Desmorat Hervé,
Zarski JeanPierre,
Barbare JeanClaude,
Chambre Jeanfrançois,
Pariente E. Alexandre,
Roulot Dominique,
Beaugrand Michel
Publication year - 1992
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840150115
Subject(s) - medicine , alcoholic hepatitis , gastroenterology , placebo , glucagon , insulin , randomized controlled trial , cirrhosis , hepatitis , mortality rate , hepatic encephalopathy , multicenter trial , surgery , alcoholic liver disease , multicenter study , pathology , alternative medicine
Severe alcoholic hepatitis is still a therapeutic challenge. It has been recently advocated that a 3‐wk infusion with insulin and glucagon reduces its short‐term mortality rate. A multicenter, randomized, single‐blind, sequential trial was designed to compare this treatment with placebo. The triangular boundary was defined with α = 0.05, β = 0.10 and estimated survival at 4 wk of 50% with placebo, 75% with treatment. Patients with biopsy‐proven severe alcoholic hepatitis (presence of one or more of three criteria: encephalopathy, prothrombin activity ⩽ 50%, bilirubinemia ⩾ 100 μmol/L) were randomized into two groups; one treatment group received an infusion (12 hr/day) of an association of insulin (30 IU) and glucagon (3 mg), and a control group received an infusion of glucose. Treatments were administered during a 3‐wk period, and the mortality rate was noted at 4 wk. The decision to discontinue the trial was reached on the basis of results from the first 44 patients. Overall results were assessed in the 72 patients included at the time of this decision (treatment group: n = 37; control group: n = 35). Fifty‐three patients had cirrhosis. No significant differences were noted between the two groups at inclusion on the basis of clinical, laboratory and histological criteria. The mortality rate was not significantly different in the two groups; 10 patients (27%) in the treatment group and 5 patients (14%) in the control group died. Causes of death were similar in the two groups and consisted primarily of gastrointestinal hemorrhage, hepatic failure and infectious events. Only one minor case of hypoglycemia was observed. Treatment by the infusion of an association of insulin and glucagon is not beneficial in patients with severe biopsy‐proven alcoholic hepatitis. (H EPATOLOGY 1992;15:76–81).