| Methods |
Randomised clinical trial |
| Participants |
Country: Belgium.
Number randomised: 44.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 44.
Average age: 49 years.
Females: 12 (27.3%).
Inclusion criteria: 1. Biopsy proven AAH. 2. Maddrey Discriminant Function of 32 or more
Exclusion criteria: not reported |
| Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 25): N‐acetyl‐cysteine 300 mg/kg intravenously.
Group 2 (n = 19): placebo.
Duration: 14 days |
| Outcomes |
mortality, adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Patients were randomised".
Comment: Further details were not available. |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| 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. |
