| Methods |
Randomised clinical trial |
| Participants |
Country: India.
Number randomised: 62.
Post‐randomisation dropouts: 2 (3.2%).
Revised sample size: 60.
Average age: 42 years.
Females: 0 (0%).
Inclusion criteria: 1. History of chronic alcohol intake of more than 50 g/day. 2. Maddrey Discriminant Function of 32 or more. 3. AST:ALT ratio higher than 2 (with absolute value of 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. HIV‐ positivity. 5. History of abstinence from alcohol in the last month. 6. Infection. 7. Sepsis. 8. Spontaneous bacterial peritonitis. 9. Acute pancreatitis. 10. Gastro‐intestinal bleeding. 11. Hepatorenal syndrome. 12. Uncontrolled diabetes mellitus. 13. Systemic hypertension. 14. Heart failure. 15. Pulmonary disease. 16. Malignancy at the time of inclusion or in the previous 3 months. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 30): pentoxifylline 400 mg thrice daily plus glucocorticosteroids (prednisolone 40 mg once daily).
Group 2 (n = 30): pentoxifylline 400 mg thrice daily.
Duration: 4 weeks |
| Outcomes |
mortality, adverse events, decompensated cirrhosis. |
| Notes |
Reasons for post‐randomisation dropouts: one patient in Group 1 developed severe vertigo within 7 days after starting PTX and one patient in Group 2 withdrew voluntarily from the study and hence they were excluded. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "The recruited patients were then divided into 2 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 |
Low risk |
Quote: "The investigator, who allocated the patients to the groups, administered the drugs and collected the clinical and laboratory data, as well as statisticians were all blinded regarding the nature of the pharmacotherapy". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The investigator, who allocated the patients to the groups, administered the drugs and collected the clinical and laboratory data, as well as statisticians were all blinded regarding the nature of the pharmacotherapy". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "One patient in Group 1 developed severe vertigo within 7 days after starting PTX and one patient in Group 2 withdrew voluntarily from the study and hence they were excluded".
Comment: there were post‐randomisation dropouts. |
| 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. |
