| Methods |
Randomised clinical trial |
| Participants |
Country: India.
Number randomised: 70.
Post‐randomisation dropouts: 2 (2.9%).
Revised sample size: 68.
Average age: 47 years.
Females: 1 (1.5%).
Inclusion criteria: 1. History of chronic alcohol intake of more than 50 g/d. 2. Clinical and biochemical features of severe alcoholic hepatitis [Maddrey Discriminant Function of 32 or greater, aspartate aminotransferase‐ alanine aminotransferase ratio higher than 2 (with AST lower than 500 IU/L and ALT lower than 200 IU/L)].
Exclusion criteria: 1. Acute or chronic viral hepatitis. 2. Autoimmune liver disease. 3. Wilson’s disease. 4. History of abstinence from alcohol in the last month. 5. Seropositivity for HIV. 6. Infection, sepsis or spontaneous bacterial peritonitis. 7. Gastrointestinal bleeding. 8. Hepatorenal syndrome. 9. Acute pancreatitis. 10. Any other severe associated disease (uncontrolled diabetes, hypertension, heart failure, pulmonary disease or malignancy) at the time of inclusion or in the previous 3 months. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 34): pentoxifylline (400 mg thrice daily ) plus placebo once daily.
Group 2 (n = 34): glucocorticosteroids (prednisolone 40 mg once daily) plus placebo.
Duration: 4 weeks |
| Outcomes |
mortality, adverse events, decompensated cirrhosis. |
| Notes |
Reasons for post‐randomisation dropouts: 2 withdrawal of consent after randomisation, excluded from the analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "The included patients were divided into two groups by a computer‐generated randomisation table". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "After the initial 4 weeks, the study was opened and the patients allocated to the different groups were revealed".
Comment: Further details were not available. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The investigators who allocated the patients to the groups, administered the drugs and collected the clinical and laboratory data, as well the statisticians, were all blinded regarding the nature of the pharmacotherapy". |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Quote: "Two patients in group Ⅱ withdrew voluntarily from the study and were excluded". |
| Selective reporting (reporting bias) |
Low risk |
Comment: all important outcomes were reported. |
| For‐profit bias |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: there was no other bias. |
