Liaw 1994.

Methods	Methodological quality Generation of allocation sequence: randomisation schedules (adequate). Allocation concealment: randomisation code was held by an independent agent and was not broken until the final evaluation (adequate). Double blinding: placebo tablets (adequate). Follow‐up: complete follow up (adequate).
Participants	Inclusion criteria of patients (1) Age 16 to 65. (2) Heterosexual male. (3) HBsAg positivity for at least 6 months. (4) HBeAg positivity for at least 6 months. (5) Raised ALT (N<40 U/liter). (6) Liver biopsy taken within the past 3 months showing CAH or chronic lobular hepatitis (CLH) with hepatic expression of HBcAg. (7) HBV‐DNA in serum on at least two occasions 1 month apart before entry. (8) Patients with cirrhosis were also included. Exclusion criteria of patients (1) Antiviral or immunosuppressive treatment within 1 year prior to to entry. (2) HDV infection. (3) Intravenous drug abuse. (4) Decompensated liver disease or other serious illness which might interfere with this trial. (5) Alphafetoprotein above 100ng/ml concomitant ALT elevation. Characteristics of included patients Patients were stratified according to histologic diagnosis (CAH or CLH) and randomly assigned to one of the following 3 groups: Gluco+IFN ‐ 39 patients Mean age: 32 Mean ALT : 231 U/l Cirrhosis: 7.7 % Control+IFN ‐ 37 patients Mean age: 30 Mean ALT: 260 U/l Cirrhosis: 13.5 % Control group ‐ 40 patients Mean Age: 32 Mean ALT 240U/l Cirrhosis: 12.5 %
Interventions	Gluco+IFN: 4 weeks of prednisolone: 30 mg/day for 3 weeks then 15 mg/day for the 4th week. 2 weeks of no treatment. 12 weeks of interferon: 5‐day induction 4 MU/m2 for 3 days + 6 MU/m2 for 2 days followed by 6 MU/m2 3 times weekly for 11 weeks. Total prednisolone dosis: 735 mg/4 weeks. Control+IFN: 4 weeks of matching placebo. 2 weeks of no treatment. 12 weeks of interferon: 5‐day induction 4 MU/m2 for 3 days + 6 MU/m2 for 2 days followed by 6 MU/m2 3 times weekly for 11 weeks. Control group: 18 weeks of placebo capsules.
Outcomes	Loss of HbeAg and HBV‐DNA, ALT normalisation, changes in Knodell score. Follow‐up period: 12 months after the end of treatment.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate