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Effect of oral cromolyn sodium on CKD-associated pruritus and serum tryptase level: a double-blind placebo-controlled
Ghazal Vessal1, Mohammad Mehdi Sagheb, Saman Shilian
1Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. gvessal@yahoo.com
Insights
Cromolyn sodium (CS) significantly reduced itching in end-stage renal disease patients undergoing hemodialysis. This treatment effectively alleviates renal itch without altering serum tryptase levels.
Area of Science:
- Nephrology
- Dermatology
- Clinical Pharmacology
Background:
- Generalized pruritus is a common and debilitating complication for patients with end-stage renal disease (ESRD).
- The underlying mechanisms of ESRD-related pruritus remain unclear, and current therapeutic options offer limited efficacy.
- This study represents the first clinical trial to investigate the therapeutic potential of cromolyn sodium (CS) for managing renal itch.
Purpose of the Study:
- To evaluate the efficacy of cromolyn sodium (CS) in alleviating pruritus in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD).
- To investigate the potential role of serum tryptase levels in mediating the effects of CS on renal pruritus.
Main Methods:
- A randomized, placebo-controlled trial involving 62 hemodialysis (HD) patients experiencing pruritus.
- Participants received either cromolyn sodium (CS) or a placebo (135 mg three times daily) for 8 weeks, followed by a 4-week post-treatment observation period.
- Pruritus severity was assessed using a visual analogue scale (VAS) during dialysis sessions, and serum tryptase levels were measured at baseline, after treatment, and post-discontinuation.
Main Results:
- Analysis included 21 patients in the CS group and 19 in the placebo group who completed the study.
- A statistically significant reduction in pruritus severity was observed in the CS group compared to the placebo group (VAS scores decreased from 8.48 to 0.9).
- While serum tryptase levels showed a non-significant decrease in the CS group (P = 0.214), this did not correlate with the observed improvement in pruritus.
Conclusions:
- Cromolyn sodium (CS) demonstrates significant efficacy in reducing the severity of pruritus experienced by hemodialysis (HD) patients.
- The therapeutic benefit of CS in managing renal itch is not attributable to a reduction in serum tryptase levels.
Background:
Generalized pruritus is a significant complication in end-stage renal disease patients. The mechanism is unknown and most treatments are ineffective. This study is the first clinical trial designed to evaluate the effect of cromolyn sodium (CS) on renal itch.
Methods:
Sixty-two haemodialysis (HD) patients with pruritus were enrolled into the study and were randomly assigned to receive CS or placebo (135 mg three times daily) for 8 weeks. Patients were asked to record the severity of their pruritus on each dialysis session on a visual analogue scale (VAS) during the 8 weeks of treatment and 4 weeks following discontinuation of treatment. Serum tryptase levels were determined at baseline, after 8 weeks of treatment and 4 weeks after discontinuation of treatment.
Results:
Data were analysed in 21 patients in the CS group and 19 patients in the placebo group that completed the study. A significant difference was seen in the severity of pruritus between the two groups during the period of study. Level of pruritus decreased from 8.48 +/- 2.2 to 0.9 +/- 1.8 after 8 weeks of treatment with CS. Geometric mean of serum tryptase at baseline and 8 weeks after treatment were 21.3 and 19.5 ng/ml for the CS group and 18.03 and 18.2 ng/ml for the placebo group, respectively. Although the geometric mean of tryptase had decreased in the CS group, this decrease was not statistically significant (P = 0.214).
Conclusion:
CS can significantly reduce the severity of pruritus in HD patients, but this effect is not due to a decrease in serum tryptase level.
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