Cianciara 1992.
Methods | Methodological quality Generation of allocation sequence: not reported (unclear). Allocation concealment: not reported (unclear). Double blinding: placebo tablets (adequate). Follow‐up: not described (Inadequate). | |
Participants | Inclusion criteria of patients
(1) Chronic hepatitis B by histopathological examination.
(2) HBeAg positive.
(3) DNA‐polymerase positive.
(4) Transaminase levels twice above upper normal limit. Exclusion criteria of patients (1) Anti‐HDV positive. (2) Anti‐HIV positive. (3) Age below 18 years. (4) Antiviral or immunomodulating treatment during the last 12 months. (5) Non‐compensated hepatic cirrhosis. (6) Creatinine > 2.3 mg/dL. (7) Heamostasis disturbances. (8) Contraindications to glucocorticosteroids. (9) Acute worsening of hepatic disease. (10) Pregnancy. (11) Respiratory/circulatory insufficiency. Characteristics of included patients Gluco+IFN ‐ 22 patients Mean age: 36.2 Males/females: 18/4 Mean ALT levels: 91.2 IU/L Control+IFN ‐ 22 patients Mean age: 38.3 Males/females: 13/9 Mean ALT levels: 88.6. |
|
Interventions | Gluco+IFN
4 weeks of prednisolone (0.6 mg/kg/day for 2 weeks, 0.45 mg/kg/day third week and 0.25 mg/kg/day fourth week).
2 weeks rest.
12 weeks IFN (10 MU/day for the first 5 days then thrice weekly for 11 weeks).
Total prednisolone dose: 931 mg/ 4 weeks. Control+IFN 4 weeks of placebo. 2 weeks rest. 12 weeks IFN (10 MU/day for the first 5 days then thrice weekly for 11 weeks). |
|
Outcomes | Anti‐HBe positivity, Loss of HBeAg, ALT normalisation. Follow‐up period: 12 months after the end of treatment. |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |