AIM: 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.
RCT Entities:
AIM: 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: Martin Kimmel; Dominik Mark Alscher; Robert Dunst; Niko Braun; Christoph Machleidt; Thomas Kiefer; Christina Stülten; Heiko van der Kuip; Christiane Pauli-Magnus; Ulrich Raub; Ulrich Kuhlmann; Thomas Mettang Journal: Nephrol Dial Transplant Date: 2005-10-25 Impact factor: 5.992
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