ABSTRACT
To determine the efficacy of oral nicotinamide with placebo to ameliorate uremic pruritus (UP), we conducted a prospective, randomized, double-blind, 4-week study in 50 chronic kidney disease patients with refractory UP. The patients were randomly allocated to nicotinamide tablet 500 mg twice/day or placebo. All anti-pruritic agents were discontinued at least two weeks before the study. All the patients completed the period of the study and their severity of pruritus was evaluated before the start of the study and at the end of each week for four weeks by using a traditional Visual Analogue Scale and a modified questionnaire method (pruritus score). The average pruritus score before administration of oral nicotinamide in the study group and that in the placebo group was 2.96 ± 0.45 and 2.72 ± 0.37, respectively. In the nicotinamide group, the average score of pruritus gradually reduced to 1.29 ± 1.08 and in the placebo group it gradually decreased to 1.52 ± 1.61 at the end of the fourth week. There was no significant difference between the reductions of pruritus in both groups, but the interaction effect using a linear mixed model was significant between drug and time (P <0.026). We conclude that increasing the time of application of nicotinamide sodium to more than four weeks may be more effective than placebo in reducing itching in uremic patients.
Subject(s)
Niacinamide/therapeutic use , Pruritus/drug therapy , Vitamin B Complex/therapeutic use , Administration, Oral , Adolescent , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged , Niacinamide/administration & dosage , Prospective Studies , Pruritus/etiology , Pruritus/physiopathology , Treatment Outcome , Uremia/complications , Vitamin B Complex/administration & dosage , Young AdultABSTRACT
BACKGROUND: Chronic kidney disease (CKD)-associated pruritus is a significant clinical symptom affecting more than 50% of patients on hemodialysis. The availability of effective therapeutic options for management of CKD-associated pruritus remains a treatment challenge. OBJECTIVE: The aim of this study was to compare cromolyn sodium cream 4% with placebo for the treatment of renal pruritus. METHODS: A randomized, double-blind, prospective, 4-week study was designed. 60 patients with ESRD in our dialysis ward were randomly allocated to cromolyn sodium cream 4% or placebo. All of them completed the study period and their pruritus levels were evaluated 5 times (before the start of the study and at the end of each week for 4 weeks) using a Visual Analogue Scale (VAS). RESULTS: The average pruritus score before administration of the drug in cromolyn sodium 4% and placebo group had been 2.5 ± 1.1 and 2.7 ± 1.3, respectively. In the cromolyn sodium 4% group the average score of pruritus gradually reduced to 0.3 ± 1.3 and in the placebo group it gradually decreased to 1.3 ± 1.4 at the end of Week 4. Method of t-test repeat analytical measurement indicated that there is no significant difference between reduction of pruritus in cromolyn 4% and placebo groups in the first and second week of the study, but in third and fourth week there were significant differences in reducing pruritus in favor of cromolyn sodium 4% (p < 0.04). CONCLUSION: According to our study cromolyn sodium cream 4% was more effective than placebo in reducing pruritus in uremic patients. We suggest to our colleagues to consider this treatment when facing a patient suffering from this symptom.
