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

Cho 1997.

Study characteristics
Methods
  • Study design: cross‐over RCT

  • Time frame: not reported

  • Duration of study/follow‐up: 12 weeks (2‐week baseline included, and 2‐week washout in between

Participants
  • Setting: single centre (inpatients)

  • Country: Taiwan

  • Inclusion criteria: patients with moderate to severe pruritus on HD (Kt/V > 1.0)

  • Number: treatment group (12); control group (10)

  • Mean age ± SD: 62 ± 4 years

  • Sex M/F: 14/8

  • Relevant comorbidities: not reported

  • Exclusion criteria: dermatitis; obstructive biliary disease; DM, or malignancy

Interventions Treatment group
  • Capsaicin cream (topical): 0.025%, 4 times/day for 4 weeks


Control group
  • Placebo cream: 4 times/day for 4 weeks

Outcomes
  • 4‐point pruritus severity scale

Notes
  • No declared source of funding

  • Correspondence: Der‐Cherng Tarng, MD, Division of Nephrology,

  • Veterans General Hospital‐Taipei, No 201, Sec 2 Shih‐Pai Road, Taipei. 11217, Taiwan

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk QUOTE: "Treatment order was arranged from computer generated numbers"
Allocation concealment (selection bias) Low risk QUOTE: "by a coauthor who did not participate in observations"
Blinding of participants and personnel (performance bias)
All outcomes Low risk QUOTE: "Double blinded" and "were unknown by the observers and patients"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double blind, patients made self‐evaluations, base creams ""were unknown by the observers and patients"
Incomplete outcome data (attrition bias)
All outcomes Low risk All enrolled patients completed the trial and were analysed.
Selective reporting (reporting bias) Low risk Baseline and post interventions results fully reported
Intervention level data report with patient level graphical comparison comparisons provided. Correlation may inflate standard error. Carry‐over effects unlikely due to washout periods.
Other bias Low risk No evidence of publication, funding, or other confounding bias