Hinrichsen 2002.
Methods | Randomised clinical trial with two‐group design. Samlpe size calculation: unclear, not described. Intention‐to‐treat analysis: used. |
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Participants | Country: Germany. Number of participants randomly assigned: 72; 41 men and 31 women. All participants were treatment‐naive. All participants were infected with HCV genotype two and three. Inclusion and exclusion criteria: none stated. |
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Interventions | Participants were randomly assigned to two groups.
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Outcomes | Primary outcomes were sustained and end of treatment virological responses. Other outcome reported is quality of life. Limit for hepatitis C virus RNA detection was 50 IU/mL. |
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Notes | The report is abstract; because the study has not been published yet, no data about inclusion and exclusion criteria are provided. Study author contacted for additional information, but no data obtained. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comments: Method used to perform sequence generation is not mentioned. |
Allocation concealment (selection bias) | Low risk | Comments: Allocation concealment is not mentioned. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comments: Blinding is not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: The trial seems to have addressed incomplete outcome data adequately. |
Selective reporting (reporting bias) | Unclear risk | Comment: All clinically relevant and reasonably expected outcomes were reported. |
Other bias | Low risk | Comment: The trial seems to be free of other sources of bias. |