Lok 1992.
| Methods | Methodological quality Generation of allocation sequence: described as randomised (unclear). Allocation concealment: (adequate). Double blinding: placebo tablets (adequate). Follow‐up: an unspecified number of patients (>3) had premature termination of treatment (Inadequate). | |
| Participants | Inclusion criteria of patients
113 patients were included.
(1) Ethnic Chinese.
(2) Age 18‐60 years.
(3) HBsAg positive for more than 6 months.
(4) HBeAg positive.
(5) HBV DNA positive.
(6) Stable serum HBV DNA and ALT levels on at least three occasions, 1 month apart during the 6 months before entry. Exclusion criteria of patients 33 patients were excluded due to: (1) Decompensated liver disease. (2) Platelet counts of < 100x109/L. (3) Prothrombin time > 3 seconds longer than control. (4) Severe systemic illness. (5) Immunosuppressive or antiviral therapy within the preceding 12 months. (6) Refusal of contraception in women of childbearing age. (7) Alcoholism. (8) HDV positive. (9) anti‐HIV positive. Characteristics of included patients Gluco+IFN ‐ 40 patients Male/female: 24/16 Mean age: 28 Control+IFN ‐ 39 patients Male/female: 25/14 Mean age: 29 Control group ‐ 36 patients Male/female: 22/14 Mean age: 28. |
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| Interventions | Gluco+IFN:
6 weeks of oral prednisone: 45/30/15 mg/day each for 2 weeks.
2 weeks rest.
16 weeks IFN: recombinant IFN alfa‐2b 10 MU/thrice weekly s.c.
Total prednisone dosis: 1260 mg/ 6 weeks. Control+IFN: 6 weeks placebo: tapered course of matching oral placebo. 2 weeks rest. 16 weeks IFN: recombinant IFN alfa‐2b 10 MU/thrice weekly s.c. Control group: No treatment. |
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| Outcomes | Loss of HBV DNA, HBeAg and HBsAg, Biochemical and histological response (only available for responders versus non‐responders). Follow‐up period: 6 months after the end of treatment. |
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| Notes | Patients with elevated ALT levels were separately randomised from those with normal ALT levels. 6 patients from the control group were re‐randomised to the treatment groups. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |