Feily 2012.
Methods | RCT Vehicle‐controlled Parallel‐group design |
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Participants | Pruritus: UP Description: participants with ESRD who were treated with haemodialysis Number of participants randomised: 60 Number of participants evaluable: 60
Withdrawals/dropouts: 0 Reason for dropout: NA Age (mean ± SD): 53 years ± 11.4 Sex (male/female): 38 (63%)/22 (37%) Underlying disease(s): ESRD Participant pool: single‐centre Setting: inpatient Haemodialysis: 3 times per week Baseline pruritus assessment: yes Duration/severity of pruritus: for at least 6 weeks without any systemic or topical treatment for the pruritus Baseline parameters: mean VAS ± SD:
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Interventions |
Additional medication: all other anti‐pruritus treatments were prohibited during the study; other routine medications were allowed Route of administration: topical Duration of treatment: 4 weeks Follow‐up: no information |
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Outcomes | Pruritus assessment: VAS (0‐5, 0: no pruritus and 5: the worst pruritus) Adverse events |
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Notes | Results in abstract and full text (e.g. Table 1) are conflicting; we worked with results stated in the abstract. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[S]imple random table" |
Allocation concealment (selection bias) | Unclear risk | "[P]atients were randomly allocated to one of the two arms of the study" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The medications used were not revealed to their physicians" "A similar tube was used to store CS 4% to make both creams to look physically identical" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The placebo was formulated by a pharmacist to have a similar base with the drug but not containing the active ingredient and stored in a tube without any labelling. A similar tube was used to store CS 4% to make both creams to look physically identical" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts; unclear if intention‐to‐treat analysis was used |
Selective reporting (reporting bias) | Unclear risk | No indication of selective reporting; no protocol or registration number |
Size of study (possible biases confounded by small size) | High risk | Number of participants randomised: 60 |
Other bias | High risk | Results in abstract and full text (e.g. Table 1) are conflicting |