To assess the benefits and harms of glucocorticosteroids administered in any route, dose, and duration versus placebo or no intervention in people with alcoholic hepatitis in terms of death, health-related quality of life, and complications.
Excessive alcoholic consumption may damage the liver, causing alcoholic hepatitis. The first stage of liver damage in alcoholic hepatitis is usually reversible if people abstain from drinking, but the risk of the disease developing further and getting more complications increases with resumed drinking. A heavy drinker is considered a person who consumes more than 60 g to 80 g (for men) or more than 20 g (for women) alcohol per day. Only 10 to 35 people out of 100 heavy drinkers with evidence of excessive fat in the liver would most probably develop alcoholic hepatitis. With time, alcoholic hepatitis will cause liver fibrosis (scarring of the liver) or liver cirrhosis with complications (bleeding, infections, liver cancer, etc).
Glucocorticosteroids are considered to have anti-inflammatory effects (relieving pain, oedema, fever). They are administered to people with alcoholic hepatitis in order to repair their liver injury. However, the benefits and harms of glucocorticosteroids are not well studied in randomised clinical trials, and therefore, it is uncertain if they should be used in clinical practice for people with alcoholic liver disease.
The date of the last search was 20 October 2016.
Sixteen randomised clinical trials compared glucocorticosteroids with placebo or no intervention in people with alcoholic hepatitis. Fifteen trials provided data for analysis (927 participants received glucocorticosteroids and 934 participants received placebo or no intervention). Glucocorticosteroids were administered orally or as an injection for a median of 28 days (range 3 days to 12 weeks). The trial participants were between 25 and 70 years old (men: 65%) and had different stages of alcoholic liver disease. Trial participants were followed up to the moment of discharge from the hospital, or until they died (a median of 63 days), or for at least a year. Not all trials reported the follow-up of participants. The trials were conducted in France, India, UK, and USA. Two trials administered pentoxifylline to both glucocorticosteroids and placebo intervention groups.
Nine of the trials were industry-funded.
Quality of evidence
The overall quality of evidence was very low, low, or moderate, and all the trials were at high risk of bias, which means that there is possibility of drawing wrong conclusions, exaggerating benefits or underestimating harms of glucocorticosteroids because of the way that the trials were conducted and analysed.
Glucocorticosteroids did not benefit clinical outcomes of importance to people with alcoholic liver disease, such as mortality, no matter the cause, and health-related quality of life. In addition, glucocorticosteroids may increase the number of adverse events. We cannot exclude benefits and harms of glucocorticosteroids but researchers need to study further their effects in high-quality, placebo-controlled, randomised clinical trials. Such trials ought to be registered before they are launched and openly report depersonalised individual participant data so that individual participant data meta-analysis can be conducted.