Nakhaee 2015.
Methods | RCT Comparative trial three‐armed trial Cross‐over design |
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Participants | Pruritus: UP Description: participants with ESRD who were treated with haemodialysis Number of participants randomised: 25 Number of participants evaluable: 23
Withdrawals/dropouts: 2 (vinegar solution group) Reason for dropout: 2 kidney transplantations Age (mean ± SD): 57.04 years ± 12.20 Sex (male/female): 17 (73.9%)/6 (26.1%) Underlying disease(s): ESRD Participant pool: single‐centre Setting: inpatient Haemodialysis (mean ± SD): duration: 3.55 ± 2.78; frequency (per week): 2.57 ± 0.51 Baseline pruritus assessment: yes Duration/severity of pruritus (mean ± SD): 5.19 years ± 4.85 Baseline parameters:
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Interventions |
Additional medication: NA Route of administration: intervention 1 and 2: topical; intervention 3: oral Duration of treatment: 2 weeks Follow‐up: no information |
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Outcomes | Clinical response to treatment: complete response, partial response and no response VAS: a 10 cm long line on which 0 referred to no pruritus and 10 showed the most severe pruritus the patient could imagine Adverse events Additional outcomes: frequency, surface percentage of total body surface, verbal descriptor, consequences |
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Notes | Washout: 72 hours "All the patients performed the interventions completely." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were assigned by random numbers to 3 groups |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible due to type of interventions |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding not possible due to type of interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 kidney transplantations |
Selective reporting (reporting bias) | Low risk | No indication |
Size of study (possible biases confounded by small size) | High risk | Number of participants randomised: 23 |
Other bias | Low risk | The study protocol was registered in the Iranian Registry of Clinical Trials (IRCT2013021912525N1); http://www.irct.ir/searchresult.php?id=12525&number=1 |