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. 2016 Nov 16;2016(11):CD008320. doi: 10.1002/14651858.CD008320.pub3

Ghent 1988.

Methods RCT
Placebo‐controlled
Cross‐over design
Participants Pruritus: CP
Description: participants with PBC
Number of participants randomised: 9
  • Group A (rifampicin ‐ placebo): 4

  • Group B (placebo ‐ rifampicin): 5


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
Interventions
  • Intervention 1: rifampicin (150 mg 2x/d for serum bilirubin level > 51 µmol/L (3 mg/dL); 150 mg 3x/d for serum bilirubin level < 51 µmol/L)

  • Intervention 2: placebo


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
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
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