Ghent 1988.
Methods | RCT Placebo‐controlled Cross‐over design |
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Participants | Pruritus: CP Description: participants with PBC Number of participants randomised: 9
Number of participants evaluable: 9 Withdrawals/dropouts: 0 Reason for dropout: NA Age (years): 45‐64 Sex (male/female): 1/8 Underlying disease(s): primary biliary cirrhosis Participant pool: single‐centre Setting: outpatient Haemodialysis: NA Baseline pruritus assessment: 1 week baseline record of the pruritus VAS was obtained for 5 subjects prior to the study Duration/severity of pruritus: persistent pruritus Baseline parameters: no information |
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Interventions |
Additional medication: cholestyramine (n = 5) Route of administration: oral Duration of treatment: 2 weeks (2 weeks washout ‐ 2 weeks cross‐over) Follow‐up: no information |
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Outcomes | Pruritus assessment: VAS (0‐100 mm) Adverse events: none observed Additional outcomes: urine analysis, blood count, serum bilirubin, creatinine, alanine transaminases, aspartate transaminases, alkaline phosphatases, fasting total serum bile acids |
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Notes | Presentation of study results is inappropriate | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The order of treatment was random . . .." Method of randomisation not stated |
Allocation concealment (selection bias) | Low risk | "The coding of the medication order was done by an independent research pharmacist." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | ". . . in a double‐blind manner." Unclear who was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All completed and analysed; unclear if used intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting |
Size of study (possible biases confounded by small size) | High risk | Number of participants randomised: 9 |
Other bias | Unclear risk | Small number of participants |