Dollinger 2005.
Methods | Study design: randomised multicentre trial. ITT analysis: performed. Sample size calculation: not mentioned. |
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Participants | Country: Germany. Total number (sample size): 40. Age: not mentioned. Sex (male): not mentioned. Comorbidity: not mentioned. Genotype: one‐b. Previous HCV treatment: non‐responders to previous combination treatment with IFN and RBV. Inclusion criteria: chronic hepatitis C diagnosed by the following.
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Interventions | Group A (n = 22).
Group B (n = 18).
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Outcomes | Early response rate (24 weeks of treatment); end‐of‐treatment response rate (52 weeks of treatment); sustained response rate (six months after treatment); adverse events. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comments: Method of sequence generation is not mentioned. |
Allocation concealment (selection bias) | Unclear risk | Comments: Allocation concealment is not mentioned. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comments: Blinding to outcome assessors is not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: Incomplete outcome data were addressed adequately. |
Selective reporting (reporting bias) | Low risk | Comment: All clinically relevant and reasonably expected outcomes were reported. |
Other bias | Unclear risk | Quote: "The study was supported by a grant of Yamanouchi and Essexpharma, Germany". Comments: The study may contain conflict of interest risk of bias. |