Young 2009.
Methods | RCT Vehicle‐controlled Parallel‐group design |
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Participants | Pruritus: UP Description: participants with ESRD on haemodialysis Number of participants randomised: 28
Number of participants evaluable: 27
Withdrawals/dropouts: 1 Reason for dropout: unrelated subject death Age (range): 18‐70 years Sex (male/female): 14/14 Underlying disease(s): ESRD Participant pool: single‐centre Setting: inpatient Haemodialysis: at least 3 months Baseline pruritus assessment: yes Duration/severity of pruritus: symptoms of itch in a regular pattern over 6 months; at least 2 episodes of itch > 2 minutes within 2 weeks Baseline parameters: (mean ± SD)
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Interventions |
Additional medication: no information Route of administration: topical to all affected areas of pruritus/2x daily Duration of treatment: 4 weeks Follow‐up: baseline ‐ week 1‐ week 4 |
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Outcomes | Pruritus assessment: VAS 10 cm Adverse events Additional outcomes:
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised; method not stated |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind; 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 | One participant lost because of unrelated subject death; not reported if intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | Inclusion and exclusion criteria inadequately described; insufficient data on pruritus VAS (no confidence interval, only graphical illustration) |
Size of study (possible biases confounded by small size) | High risk | Number of participants randomised: 28 |
Other bias | Unclear risk | Assessment of compliance not stated; possible carryover effect not mentioned |