Methods | Randomised clinical trial. | |
Participants | Country: China. Number randomised: 33. Post‐randomisation dropouts: 0 (0%). Revised sample size: 33. Mean age: 54 years. Females: 9 (27.3%). Genotype 1: not stated. Genotype 3: not stated. Other genotypes: not stated. Mean follow‐up period in months (for all groups): 12. Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 2 groups. Group 1: interferon‐alpha‐2b (n = 16). Further details: interferon‐alpha‐2b 3 MU 3 times per week. Group 2: no treatment (n = 17). Duration of treatment: 3 months. |
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Outcomes | Sustained virological response. Frequency of adverse events. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "These patients were randomly allocated to either the IFN‐treated group or the control group by a random number table." |
Allocation concealment (selection bias) | Unclear risk | Comment: information not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Seventeen patients in the control group received no specific treatment." Comment: placebo not used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information not available. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Only one patient in the control group was unwilling to continue and withdrew from the study after 6 months of follow up." Comment: there were post‐randomisation dropouts. |
Selective reporting (reporting bias) | Low risk | Comment: all important outcomes were reported. |
For‐profit bias | High risk | Quote: "This study was supported by grants from the National Science Council (NSC82‐0419‐B075‐092) and National Health Research Institutes (DOH‐83‐HR‐208), Republic of China. Drug supplied by pharm. company." |
Other bias | Low risk | Comment: no other bias. |