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.
RCT Entities:
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 uremicpatients. We suggest to our colleagues to consider this treatment when facing a patient suffering from this symptom.