Vajro 1996.
Methods | Methodological quality Generation of allocation sequence: described as randomised but 4 out of 31 patients were re‐allocated after randomisation (unclear). Allocation concealment: described as unblinded allocation (unclear). Double blinding: no or inadequate methods of blinding (unclear). Follow‐up: (adequate). | |
Participants | Inclusion criteria of patients
(1) Inclusion criteria not described, only patient characteristics. Exclusion criteria of patients (1) Previous antiviral or immunosuppressive therapy. (2) Antibody to HIV. (3) Antibody to HDV. (4) Decompensated liver disease. (5) Autoimmune disease. (6) Other serious illness. (7) Other forms of liver disease. Characteristics of included patients Control+IFN ‐ 13 patients Males/females: 9 Mean age: 6.92 Mean HBV DNA: 300 pg/ml Mean ALT: 238 U/L Histology (knodell): 10.6 Gluco+IFN ‐ 9 patients Males/females: 6 Mean age: 8 Mean HBV DNA: 392 pg/ml Mean ALT: 119 U/L Histology (knodell): 8.2 Control group ‐ 9 patients Males/females: 9 Mean age: 8.91 Mean HBV DNA: 299 pg/ml Mean ALT: 117 U/L Histology (knodell): 7.6. |
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Interventions | Gluco+IFN:
6 weeks of prednisone: 2 weeks 1 mg/kg, and 4 weeks tapering.
2 weeks washout.
1 year of IFN: 10 MU/m2 recombinant IFN alfa‐2b three times weekly .
Total prednisone dosis: 1575 mg/6 weeks. Control+IFN: 1 year of IFN: 10 MU/m2 recombinant IFN alfa‐2b three times weekly. Control group: No treatment. |
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Outcomes | HBsAg negativity, Anti‐HBs positivity, HBeAg negativity, anti‐HBe positivity, HBV DNA negativity, ALT normalisation, liver histology (IFN treated patients versus non‐treated patients). Follow‐up period: 24 months after the end of treatment. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |