Perrillo 1990.

Methods	Methodological quality Generation of allocation sequence: (adequate). Allocation concealment: randomisation code unbroken until completion of treatment (adequate). Double blinding: placebo tablets (adequate). Follow‐up: 16 patients were lost to complete. follow up, only 7 are accounted for (inadequate).
Participants	545 patients were screened for the study, 376 were excluded. Inclusion criteria of patients (1) > 18 years of age. (2) HBsAg + for at least 6 months. (3) HBeAg + on 3 or more occasions, at least 1 month apart, during the 6 months before entry. (4) HBV‐DNA + on 3 or more occasions, at least 1 month apart, during the 6 months before entry. (5) ALT elevation more than 1.3 times the upper normal limit. (6) Evidence of chronic hepatitis on liver biopsy. Exclusion criteria of patients (1) Corticosteroid or antiviral therapy during the previous 12 months. (2) Pregnancy. (3) Other serious medical illnesses that might preclude. completion of the study. (4) Hematocrit values less than 30%. (5) Platelet counts below 70x109/L. (6) Granulocyte counts below 1.5x109/L. (7) Elevated serum creatinine level. (8) Alcoholism or drug abuse. (9) HDV positive. (10) HIV positive. (11) Other potential causes of liver disease. (12) Prothrombin time > 3 seconds longer than normal. (13) Serum albumin level < 30 g/L. (14) Bilirubin level > 2mg/dl. Characteristics of included patients Gluco+IFN ‐ 44 patients Mean age: 40 Male/female: 86/14(%) Mean HBV‐DNA 117 pg/ml Mean ALT: 152 U/L Control+IFN (5 MU) ‐ 41 patients Mean age: 41 Male/female: 80/20 (%) Mean HBV‐DNA: 127 pg/ml Mean ALT: 183 U/L Control+IFN (1 MU) ‐ 41 patients Mean age: 37 Male/female: 88/12 (%) Mean HBV‐DNA: 176 pg/ml Mean ALT: 182 U/L Control group ‐ 43 patients Mean age: 41 Male/female: 84/16 (%) Mean HBV‐DNA: 146 pg/ml Mean ALT 168 U/L.
Interventions	Gluco+IFN: 6 weeks of prednisone (60/40/20 mg/day every second week). 2 weeks rest. Interferon 5 MU daily for 16 weeks. Total prednisone dose: 1540 mg/ 6 weeks. Control+IFN (5 MU) 41 patients Placebo for 6 weeks. 2 weeks rest. Interferon 5 million units daily for 16 weeks. Control+IFN (1 MU) 41 patients Placebo for 6 weeks. 2 weeks rest. Interferon 1 million units daily for 16 weeks. Control group 43 patients No treatment for 24 weeks.
Outcomes	Mortality, loss of HBV DNA, HBeAg and HBsAg, ALT/AST normalisation, liver histology (only data for responders versus non‐responders) Follow‐up period: 6 months after the end of treatment.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate