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. 2020 Dec 7;2020(12):CD011393. doi: 10.1002/14651858.CD011393.pub2

Gunal 2004.

Study characteristics
Methods
  • Study design: cross‐over RCT

  • Time frame: not reported

  • Duration of study/follow‐up: 8 weeks

Participants
  • Setting: single centre (inpatients)

  • Country: Turkey

  • Health status: ESKD on HD; minimum duration of pruritus 8 weeks

  • Number: 25

  • Mean age ± SD: 55 ± 11 years

  • Sex (M/F): 14/11

  • Relevant comorbidities: not reported

  • Exclusion criteria: concomitant dermatological, liver, or metabolic diseases associated with pruritus.

Interventions Treatment group
  • Gabapentin (oral): 300 mg, 3 times/week for 4 weeks


Control group
  • Placebo (oral): 3 times/week for 4 weeks

Outcomes
  • Mean pruritis score: VAS daily with mean reported at baseline and end of the treatment period

Notes
  • No declared source of funding

  • Correspondence: Dr. Ali Ihsan Gunal; Firat University, 23200 Elazig, Turkey; igunal@yahoo.com

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk QUOTE: "On a random and blinded basis, patients were assigned to"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment
Blinding of participants and personnel (performance bias)
All outcomes Low risk QUOTE: "On a random and blinded basis, patients were assigned", "We conducted a double‐blind,"
Blinding of outcome assessment (detection bias)
All outcomes Low risk QUOTE: "double‐blinded", "The daily pruritus scores of patients were collected VAS from patient diaries.", "On a random and blinded basis, patients were assigned"
Incomplete outcome data (attrition bias)
All outcomes Low risk All enrolled patients completed the trial and were analysed. Multiple 1 week washout periods preceding intervention and control periods.
Selective reporting (reporting bias) Unclear risk All entered patients completed the trial and were analysed
Both periods combined reported with mean change and standard deviations reported in full
Intervention level data without patient level comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods
Other bias Low risk No intervention first group (however 1 week washout). No evidence of publication, funding, or other confounding bias