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

Nakhaee 2015.

Methods RCT
Comparative trial three‐armed trial
Cross‐over design
Participants Pruritus: UP
Description: participants with ESRD who were treated with haemodialysis
Number of participants randomised: 25
Number of participants evaluable: 23
  • Avena sativa group: 8

  • Vinegar solution group: 7

  • Hydroxyzine group: 8


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:
  • Intensity (mean ± SD): vinegar: 5.19 ± 1.88, avena sativa : 5.21 ± 1.69, hydroxyzine: 5.21 ± 1.82

  • Frequency (mean ± SD): vinegar: 1.95 ± 1.06, avena sativa : 2.30 ± 1.18, hydroxyzine: 2.04 ± 0.92

  • Surface % (mean ± SD): vinegar: 33.86 ± 24.11, avena sativa : 29.30 ± 23.28, hydroxyzine: 29.83 ± 22.32

Interventions
  • Intervention 1: avena sativa lotion (Spain), twice daily

  • Intervention 2: vinegar solution (30 mL synthetic white vinegar 5% in 500 mL of water), twice daily

  • Intervention 3: hydroxyzine tablet, 10 mg tablet every night


Additional medication: NA
Route of administration: intervention 1 and 2: topical; intervention 3: oral
Duration of treatment: 2 weeks
Follow‐up: no information
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
Notes Washout: 72 hours
"All the patients performed the interventions completely."
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