McHutchison 2001.
Methods | Generation of the allocation sequence: adequate (computer generated random sequence).
Allocation concealment:
adequate (sealed envelopes controlled by pharmacy).
Blinding: yes ‐ adequately blinded with identical placebo.
Follow‐up: Adequate. Twenty‐four weeks after treatment.
Six patients did not complete the treatment. Two of them were from the placebo group. Previous 'non‐responsders' to interferon therapy were stratified within the randomisation to ensure that equal numbers entered both treatment groups. |
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Participants | Inclusion criteria: patients aged 18 years or older, detectable hepatitis C antibodies, persistently elevated serum ALT during the 6 months before entry, prothrombin time less than three seconds prolonged, serum bilirubin less than 68 umol/L, and liver biopsy findings compatible with the diagnosis of chronic HVC infection Exclusion criteria: previous course of antiviral or immunosuppressive therapy within the preceding six months, other serious illness, pregnancy, other causes of liver disease, and history of significant alcohol intake. Characteristics: Prednisone ‐ interferon group: Male/Female: 15/5. Age (mean ± SD): 37.5 ± 6.6. Bilirubin (umol/L): 0.8 ± 0.4. Albumin (g/L): 43 ± 4. Prothrombin time (s): 12.3 ± 0.5. HCV genotype: 1: 14 Non‐1: 6. HCV RNA (MEq/ml): 7.8 ± 7.4. Cirrhosis: 3. Prior interferon treatment: 10. Placebo ‐ interferon group: Male/Female: 14/5. Age (mean ± SD): 42.5 ± 9.0. Bilirubin (umol/L): 0.8 ± 0.5. Albumin (g/L): 42 ± 4. Prothrombin time (s): 12.3 ± 0.0. HCV genotype: 1: 12 Non‐1: 7. HCV RNA (MEq/ml): 18.0 ± 26.5. Cirrhosis: 3. Prior interferon treatment: 10. |
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Interventions | Prednisone plus interferon group:
all patients received six weeks of a tapering dose of prednisone (60 mg, 40 mg 20 mg in two‐week intervals) followed by recombinant interferon alpha‐2b, three million units three times/week for 24 weeks. Placebo plus interferon group: all patients received identical placebo followed by interferon treatment as the prednisone group. |
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Outcomes | ALT, liver histology, and HCV‐RNA. Complete response was defined as normalisation of ALT (less than 55 IU/L). | |
Notes | We wrote to the authors asking for more information regarding the trial which they kindly replied to. No information on health economics was provided. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |