"Corticosteroids in the Treatment of Severe Alcoholic Hepatitis". The New England Journal of Medicine. 1992. 326(8):507-512. PubMed • Full text • PDF

Contents

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

In patients with severe alcoholic hepatitis, does treatment with prednisolone improve short-term survival?

Bottom Line

Treatment with prednisolone significantly improves short-term survival in patients with severe biopsy-proved alcoholic hepatitis.

Major Points

The efficacy of corticosteroids in the treatment of alcoholic hepatitis has been inconsistent in controlled trials. This study aimed to re-evaluate the hypothesis that corticosteroids could improve short-term survival in patients with severe alcoholic hepatitis, identified by discriminant-function value or spontaneous hepatic encephalopathy.

Guidelines

As of the last knowledge update, specific guidelines reflecting the results of this trial concerning the management of severe alcoholic hepatitis with corticosteroids could not be provided.

Design

- Randomized, double-blind, placebo-controlled trial
- N=61 patients with biopsy-proved alcoholic hepatitis
- Prednisolone (40 mg per day) vs placebo
- Setting: Two medical centers
- Enrollment: March 1987 to June 1990
- Primary endpoint: Death within two months

Population

Inclusion Criteria
- Long-standing history of alcoholism
- Clinical features of alcoholic hepatitis
- Biopsy-proved alcoholic hepatitis
- Spontaneous hepatic encephalopathy or discriminant-function value higher than 32

Exclusion Criteria
- Gastrointestinal bleeding or bacterial infection not controlled within 48 hours

Baseline Characteristics
- 57 patients had evidence of cirrhosis on biopsy
- 4 patients had alcoholic hepatitis and fibrosis
- Mean follow-up: Not specified

Interventions

- Randomized to either prednisolone 40 mg or placebo, given as a single morning dose for 28 days
- Patients unable to take oral medication received prednisolone or placebo intravenously

Outcomes

Primary Outcome
- At day 66 post-randomization, survival was 88±5 percent in the prednisolone group vs 45±8 percent in the placebo group (log-rank test, 10.9; P=0.001)

Secondary Outcomes
- At six months post-enrollment, cumulative survival rates were 84±6 percent for prednisolone vs 45±9 percent for placebo (log-rank test, 9.5; P=0.002)
- No major adverse effects related to corticosteroid therapy were observed

Funding

- Not specified

Further Reading

- More details and analysis can be found in the full text of the study