Methods | Randomised clinical trial. | |
Participants | Country: USA. Number randomised: 21. Post‐randomisation dropouts: 0 (0%). Revised sample size: 21. Mean age: not stated. Females: not stated. Genotype 1: 13 (61.9%). Genotype 3: not stated. Other genotypes: not stated. Mean follow‐up period in months (for all groups): 6. Inclusion criteria
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Interventions | Participants were randomly assigned to 2 groups. Group 1: pegylated interferon‐alpha (n = 9). Further details: pegylated interferon‐alpha (no further details of treatment regimen). Group 2: no treatment (n = 12). Duration of treatment: 6 months. |
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Outcomes | Sustained virological response was reported but was not reported in sufficient details to include for analysis. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: information not available. |
Allocation concealment (selection bias) | Unclear risk | Comment: information not available. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: information not available. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: information not available. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: there were post‐randomisation dropouts. |
Selective reporting (reporting bias) | High risk | Comment: some important outcomes which would generally be assessed were not reported. |
For‐profit bias | Unclear risk | Comment: information not available. |
Other bias | Low risk | Comment: there was no other bias. |
ALT: alanine transaminase; DNA: deoxy ribonucleic acid; HAV: hepatitis A virus; HBV: hepatitis B virus; HCV: hepatitis C virus; HCV‐RNA: hepatitis C virus ribonucleic acid; IM: intramuscular; ITT: intention‐to‐treat analysis; IU: international units; IV: intravenous; MU: million units.