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. 2014 Feb 28;2014(2):CD005441. doi: 10.1002/14651858.CD005441.pub3

Dollinger 2005.

Methods Study design: randomised multicentre trial.
ITT analysis: performed.
Sample size calculation: not mentioned.
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.
  • Histologically proven chronic hepatitis.

  • Hepatitis C, positive HCV‐RNA.

  • Elevated transaminases.

Interventions Group A (n = 22).
  • Drug: peginterferon alpha‐2b.

    • 1.5 µg/kg body weight.

    • Once weekly.


Group B (n = 18).
  • Drug: consensus interferon (CIFN)

    • 18 mcg/d CIFN for six weeks followed by 9 µg/d CIFN for 42 weeks.

  • Ribavirin

    • Dose: > 10.6 mg/kg body weight daily.

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.