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. 2005 Jul 20;2005(3):CD000345. doi: 10.1002/14651858.CD000345.pub2

Perez 1993.

Methods Methodological quality 
 Generation of allocation sequence: described as randomised (unclear). 
 Allocation concealment: method of allocation concealment was not reported (unclear). 
 Double blinding: no or inadequate methods of blinding (unclear). 
 Follow‐up: 53 included, 4 patients were lost to complete follow up ‐ reasons described (adequate).
Participants Inclusion criteria of patients 
 (1) HBeAg and HBV‐DNA positivity for at least six months. 
 (2) serum ALT activity at least 1.5 times the upper normal limit. 
 (3) Liver biopsy before treatment compatible with chronic hepatitis.
Exclusion criteria of patients 
 (1) Other causes of liver disease.
Characteristics of included patients 
 53 included patients 
 Mean age: 39 
 Male/females: not reported 
 Cirrhosis: 8/53 
 CAH: 39/53 
 CPH: 6/53 
 Mean ALT >100 IU/l: 53 
 HBeAg positive: 53 
 HBV‐DNA positive: 53.
Interventions Gluco+IFN : 
 6 weeks of decreasing doses of prednisone (60, 40, 20 mg daily) every 2 weeks. 
 2 weeks drug free period. 
 Interferon alfa‐2b 10 MU 3 times weekly was then administered subcutaneously for 16 consecutive weeks. 
 Total prednisone dose: 1540 mg/ 6 weeks.
Control+IFN: 
 24 weeks without treatment (functioning as controls for group 1). 
 Interferon alfa‐2b 10 MU 3 times weekly was then administered subcutaneously for 16 consecutive weeks.
Outcomes HBeAg negativity, HBV‐DNA negativity, HBsAg negativity, anti‐HBe positivity, ALT normalisation.
Follow‐up period: 
 Data collected at the end of treatment.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear