Reichen 1994.
Methods | Methodological quality Generation of allocation sequence: (adequate) Allocation concealment: central randomisation (adequate). Double blinding: placebo tablets (adequate). Follow‐up: 3 patients lost to follow up, reasons described. Virological data at the end of treatment are not available for 6 patients, no reasons given (adequate). | |
Participants | Inclusion criteria of patients
(56 out of 88 evaluated patients were included.)
(1) Age 18‐70 years.
(2) ALT at least twice the upper limit of normal.
(3) Replicating HBV infection documented for at least 6 months.
(4) CAH on biopsy. Exclusion criteria of patients (1) Lack of histological activity. (2) Alcohol abuse. (3) Spontaneous seroconversion. (4) Autoimmune liver disease. (5) HIV positivity. (6) Unwilling to participate. (7) Fertile women without adequate contraception. (8) Pregnancy or lactation. (9) Intravenous drug abuse. (10) Decompensated cirrhosis. (11) Hepatocellular carcinoma. (12) Previous interferon therapy and immunosuppressive therapy within the preceding 6 months. Characteristics of included patients All patients were HBsAg and HBeAg positive. Gluco+IFN ‐ 18 patients Male/female: 17/1 Mean age: 38 Mean ALT: 193 IU/L Mean HBV DNA: 416 pg/ml Control+IFN ‐ 19 patients Male/female: 17/2 Mean age: 43 Mean ALT 283 IU/L Mean HBV DNA 1224 pg/ml Control group ‐ 19 patients Male/female: 17/2 Mean age 39 Mean ALT: 311 IU/L Mean HBV DNA: 340 pg/ml. |
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Interventions | Gluco+IFN:
4 weeks of prednisone 50 mg for 2 weeks followed by 25 mg for another 2 weeks.
2 weeks drug free interval.
Recombinant interferon alpha‐2b injected subcutaneously at a dose of 1.5 MU three times weekly for 4 months.
Total prednisone dosis: 1050 mg/ 4 weeks Control+IFN: 4 weeks of identical looking placebo tablets. 2 weeks drug free interval. Recombinant interferon alpha‐2b injected subcutaneously at a dose of 1.5 MU three times weekly for 4 months. Control group: 4 weeks of identical looking placebo tablets. 2 weeks drug free interval. Recombinant interferon alpha‐2b injected subcutaneously at a dose of 5 MU three times weekly for 4 months. |
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Outcomes | Loss of HBeAg, HBV DNA and HBsAg, ALT levels, liver histology, adverse events. Follow‐up period: 7.5 months after the end of treatment. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |