Feriani 1998.
Methods |
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Participants |
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Interventions | Treatment group
Control group
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised centrally and separately for each study centre and block randomisation in steps of four used |
Allocation concealment (selection bias) | Low risk | No specific information provided. However central randomisation with probable low risk of selection bias |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label, may have affected symptom assessment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | High risk | Large number of participants missing between two phases of study that are not accounted for in the paper: 18/123 (14.6%) for 12 weeks; 4/73 (5.5%) for 24 week study |
Selective reporting (reporting bias) | Low risk | All relevant clinical outcomes reported |
Other bias | Unclear risk | Insufficient information to permit judgement |