Lampertico 1994

Methods	Randomised clinical trial.
Participants	Country: Italy. Number randomised: 41. Post‐randomisation dropouts: 3 (7.3%). Revised sample size: 38. Mean age: 47 years. Females: 19 (50%). Genotype 1: not stated. Genotype 3: not stated. Other genotypes: not stated. Mean follow‐up period in months (for all groups): 18. Inclusion criteria Post‐transfusion acute non‐A, non‐B/type C hepatitis: increase of serum ALT level to > 2.5 times the upper normal limit, on 2 separate occasions at least 2 weeks apart between 2 weeks and 6 months after transfusion. Exclusion criteria Aged > 60 years. Pregnancy. Previous transfusion with blood, fresh frozen plasma, or clotting factor concentrates. Treatment with immunosuppressive drugs. Malignant tumours. Antibody to HIV.
Interventions	Participants were randomly assigned to 2 groups. Group 1: interferon‐alpha‐2b (n = 22). Further details: interferon‐alpha‐2b 3 MU IM 3 times per week. Group 2: no treatment (n = 16). Duration of treatment: 3 months.
Outcomes	Sustained virological response. Biochemical response. Mortality at the end of follow‐up (18 months).
Notes	Reasons for post‐randomisation dropouts: of the 48 participants enrolled in the study, 1 refused therapy and 2 untreated people were lost to follow‐up during month 1. 7 participants (16% of total) were thought to have been infected with a non‐A, non‐B, non‐C agent.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: randomisation was computerised according to the author's reply.
Allocation concealment (selection bias)	Unclear risk	Comment: information not available.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: multicentre, prospective, open, randomised study comparing interferon treatment and no treatment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: information not available.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: some important outcomes which would generally be assessed were not reported.
For‐profit bias	High risk	Quote: "We thank Dr. Paola Mazzanti and Dr. Cristina Pintus (Schering‐Plough) for their assistance."
Other bias	Low risk	Comment: there was no other bias.