Farci 1994

Methods	Sample size: no justification. Generation of allocation schedule: by computer. Allocation concealment: yes. Intention‐to‐treat: yes. Interim analyses: no.
Participants	Patients with chronic hepatitis D (n = 42) from Italy. Inclusion criteria: age 18 to 60, positive HDV antibody, serum HDV RNA documented on three occasions in the last six months, elevated ALT for six months, histological evidence of chronic hepatitis, positive test for intrahepatic delta antigen, no signs of active HBV infection. Exclusion criteria were: antiviral therapy within six months, pregnancy, lactation, decompensated cirrhosis, clotting abnormalities precluding liver biopsy, hepatocellular carcinoma, WBC < 3000/cmm, platelets < 100,000/cmm.
Interventions	Control: no treatment (n =14). Experimental 1: interferon alfa‐2a 9 million units thrice a week (n =14). Experimental 2:interferon alfa‐2a 3 million units thrice a week (n =14). Duration : 48 weeks. Follow‐up: 6 months post treatment. Long term follow‐up: mean 32 months (24 to 48).
Outcomes	Loss of HDV RNA. Normalisation of ALT. Improvement in liver histology.
Notes	One patient lost to follow‐up in the control group. Intention to treat analysis was done throughout. Experimental 1 and 2 groups were taken together and compared with the control group. Control group did not get end of treatment biopsy. However, all groups offered six months post treatment biopsy, and these data were used for analysis of histological improvement.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated.
Allocation concealment (selection bias)	Unclear risk	"Using computer‐generated sealed envelopes, we randomly assigned patients..." It does not mention whether the envelops were opaque or not
Blinding (performance bias and detection bias) All outcomes	High risk	Unblinded trial design.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote "All patients with the exception of one in the control group were evaluated at the end of six months of follow‐up."
Selective reporting (reporting bias)	Low risk	Outcome measures adequately reported.