Guilera 2000.
| Methods | Generation of the allocation sequence: unclear (not reported).
Allocation concealment:
unclear (not reported).
Blinding: yes ‐ adequately blinded with identical placebo.
Follow‐up: Inadequate. Twenty‐four weeks after treatment. They did not describe the number and reason for dropouts. However, they used an intention‐to‐treat analyses. Results were analysed on a intention‐to‐treat basis, but the authors did not no specify what is meant by this analysis and number of drop‐outs were not reported. |
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| Participants | 156 patients from Spain with chronic hepatitis C. Inclusion criteria: ALT elevation and positive anti‐HCV for at least six months prior to the beginning of treatment, presence of HCV‐RNA in serum, and histopathological evidence of chronic hepatitis. Exclusion criteria: Patients with other causes of chronic liver diseases such as excessive ethanol consumption, current infection with hepatitis B, and metabolic or autoimmune disorders. No patients had evidence of HIV infection. Characteristics: Prednisolone ‐ interferon group: Male/Female: 56/25. Age (mean ± SD): 39 ± 11. ALT (IU/L): 123 ± 88. HCV genotype: 1: 62 Non‐1: 19. HCV RNA (copies/nanolitre): 2.0 ± 2.4. White blood cells count (nanoltire): 6.7 ± 1.9. Platelet count (nanolitre): 185 ± 48. Placebo ‐ interferon group: Male/Female: 52/23. Age (mean ± SD): 38 ± 12. ALT (IU/L): 122 ± 80. HCV genotype: 1: 61 Non‐1: 14. HCV RNA (copies/nanolitre): 1.8 ± 2.3. White blood cells count (nanolitre): 6.7 ± 1.7. Platelet count (nanolitre): 187 ± 42. |
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| Interventions | Prednisolone plus interferon group: all patients received oral prednisolone for four weeks: 0.6 mg/kg/day for two weeks, 0.45 mg/kg/day for one week and 0.25 mg/kg/day for one week. Two weeks after withdrawal of prednisolone, recombinant interferon alpha‐2b was three million units three times/week for 48 weeks.
Treatment was stopped in patients who did not respond (ALT level) after 24 weeks on interferon therapy. Placebo plus interferon group: all patients received identical placebo followed by interferon treatment as the prednisolone group. |
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| Outcomes | ALT, HVC‐RNA, and adverse events. Patients with normal level of ALT (not defined) and negative HCV‐RNA were considered as responders. | |
| Notes | No information on health economics was provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |