title: Comparison of pregabalin with ondansetron in treatment of uraemic pruritus in dialysis patients: a prospective, randomized, double-blind study.
abstract: OBJECTIVE
  Pruritus is common among patients with end-stage renal disease undergoing dialysis, and the pathogenesis can be explained by several mechanisms. However, there is no definite evidence supporting them, which limits the relative efficacy of any individual treatment option. In this paper, we aimed to compare pregabalin with ondansetron in treatment of uraemic pruritus (UP) in dialysis patients.
  
  
  METHODS
  In this 12-week prospective, randomized, and double-blind trial, we assessed the efficacy and side effects in UP patients undergoing dialysis. Patients were randomly assigned to receive 12 weeks of 75 mg twice-weekly pregabalin or 8 mg/day ondansetron or a placebo. Visits were scheduled at 0, 2, 4, 6, 8, and 12 weeks after treatment. The severity of pruritus was evaluated using Visual Analogue Scale and modified Duo's VAG Scale. Quality of sleep was evaluated using the Pittsburgh sleep quality index. The effect of UP on health-related quality of life was assessed using the Chinese version of the 12-item short-form (SF-12) general health survey. Baseline laboratory data and demographic characteristics were recorded from patient charts.
  
  
  RESULTS
  Finally, 179 (108 males, 71 females, aged 54.7±11.3 years old) out of the 188 patients completed the 12-week study. Of five patients who stopped pregabalin treatment due to side effects, two patients reported an improvement in nausea and vomiting among those receiving ondansetron. Two patients dropped out for renal transplantation. The 179 patients included 62 cases from the pregabalin group, 60 from the ondansetron group, and 57 from the placebo group. Over the 12 weeks, only pregabalin improved UP significantly. The severity of pruritus was reduced significantly in the pregabalin group compared with the ondansetron and the placebo groups. The final pruritus scores were not different between the ondansetron and the placebo groups. Pruritus absolutely disappeared in two patients following renal transplantation.
  
  
  CONCLUSIONS
  Pregabalin is an effective alternative for treatment of uraemic pruritus. Ondansetron has negligible effect on uremic pruritus and is expensive. A larger sample size may be needed to demonstrate the effect of ondansetron in uraemic pruritus.
authors.affiliation: Department of Spinal Cord Repairing, General Hospital of Jinan Military Area Command, Jinan, Shandong, People's Republic of China.
authors.forename: Ji
authors.initials: J
authors.lastname: Yue
authors.forename: Shoufeng
authors.initials: S
authors.lastname: Jiao
authors.forename: Yangfei
authors.initials: Y
authors.lastname: Xiao
authors.forename: Wei
authors.initials: W
authors.lastname: Ren
authors.forename: Tingbao
authors.initials: T
authors.lastname: Zhao
authors.forename: Jianzhong
authors.initials: J
authors.lastname: Meng
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000982:Antipruritics / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D000069583:Pregabalin; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D006435:Renal Dialysis / Q000009:adverse effects; D012720:Severity of Illness Index; D012890:Sleep; D014511:Uremia / Q000150:complications; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000982:Antipruritics; D017294:Ondansetron; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid
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