Surveillance decision

Surveillance decision

We will plan an update of the following section of the guideline:

  • Corticosteroid treatment for alcohol‑related hepatitis

Reason for the decision

We found 11 new studies relating to corticosteroid treatment for alcohol‑related hepatitis through focused surveillance search of this guideline. New evidence that could affect recommendations in this area was identified. Topic experts advised us about whether the following section of the guideline should be updated:

Corticosteroid treatment for alcohol‑related hepatitis

  • In patients with acute alcohol‑related hepatitis, what is the safety and efficacy of corticosteroids versus placebo?

    • What is the safety and efficacy of corticosteroids for acute alcohol‑related hepatitis?

The STOPAH trial (funded by the National Institute for Health Research [NIHR]) was identified which evaluated the effect of treatment with prednisolone or pentoxifylline in patients with alcoholic hepatitis and severe disease in the UK. The results indicated that prednisolone was associated with a reduction in 28‑day mortality that did not reach significance but was associated with significantly more serious infections. At 90 days and 1 year there were no significant differences in mortality rates between the treatment groups. This new evidence appears contradictory to the evidence included in the guideline as steroids were associated with a significant reduction in both all‑cause mortality at 1 month and 6 months and liver‑related mortality follow‑up at 1 month in people with severe hepatitis. At the time of development, the Guideline Committee were aware of the ongoing STOPAH trial and had the view that the results of the trial would further inform the best treatment approach for these patients.

The results of the STOPAH trial were considered alongside evidence identified at previous surveillance reviews and from a focused search of the question. Overall, the new evidence available from the recently published STOPAH trial in addition to the studies identified through previous surveillance reviews suggest that recommendation, which states that people with severe acute alcohol-related hepatitis and a discriminant function of 32 or more should be offered corticosteroid treatment, may no longer be justified. Feedback from topic experts indicated that the current recommendation on corticosteroids for acute alcohol-related hepatitis should be revisited in light of the data from the STOPAH trial.

Topic experts also highlighted that the Cochrane Hepato‑Biliary group is currently in the process of updating several reviews in this area (focusing on analyses of prednisolone and of pentoxifylline) and that it would be useful to time an update to coincide with publication of these updates. Current information from the Cochrane Hepato‑Biliary group indicates that publication of these Cochrane reviews is imminent.

Decision: This review question should be updated. The timing of the update should consider the publication of relevant Cochrane reviews in this area by the Cochrane Hepato‑Biliary group.

Other clinical areas

This exceptional surveillance review was carried out to allow us to consider the impact of the STOPAH trial results on the guideline recommendations. We did not search for new evidence relating to other clinical areas in the guideline as part of this focused surveillance.

Overall decision

After considering all the new evidence and views of topic experts, we decided that a partial update is necessary for this guideline.

See how we made the decision for further information.

This page was last updated: 06 April 2016