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. 2017 Mar 12;2017(3):CD011644. doi: 10.1002/14651858.CD011644.pub2
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
  • People who received blood transfusion due to cardiovascular surgery, other operations, or upper gastrointestinal bleeding in Veterans General Hospital, Taipei.

  • Diagnosis of acute HCV infection: serum ALT elevated above 90 IU/L (twice the upper normal value) and the seroconversion of serum antibody to HCV (anti‐HCV) or serum HCV‐RNA after blood transfusion.


Exclusion criteria
  • Estimated survival < 6 months.

  • History of interferon treatment within 12 months prior to entering trial.

  • Presence of severe systemic diseases or malignancies.

  • Women of childbearing age not using contraception and breastfeeding mothers.

  • Age < 18 years.

  • Evidence of haematopoietic dysfunction.

  • Presence of decompensated liver conditions such as hepatic encephalopathy, ascites, or a serum bilirubin level > 4 mg/dL.

  • Presence of any concurrent illness that could interfere with the investigator's assessment in the treatment of hepatitis.

  • Psychiatric disorders.

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.
Outcomes Sustained virological response.
Frequency of adverse events.
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.