Evaluation of the Efficacy and Safety of Mirtazapine in the Treatment of Uremic Pruritus in Hemodialysis Patients: A Randomized, Double-blind, Placebo-controlled Clinical Trial.

Abstract

Objective: Uremic pruritus (UP) is a prevalent and debilitating condition experienced by patients undergoing hemodialysis, influenced by multiple underlying mechanisms. Despite the availability of various treatment options, many patients still endure significant pruritus. This double-blind, placebo-controlled clinical trial aims to assess and compare the safety and efficacy of mirtazapine and hydroxyzine in treating UP and improving sleep quality in hemodialysis patients.

Methods: Twenty-seven patients in the mirtazapine group received 15 mg/night (7.5 mg for the first two nights) with a hydroxyzine placebo, while 28 patients in the hydroxyzine group received 25 mg/night (12.5 mg for the first two nights) with a mirtazapine placebo for 2 weeks. UP was assessed using the 5D-itch scale, and sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI) at baseline, weeks 2, 3, and 4. Adverse effects were recorded using the Antidepressant Side Effect Checklist at each visit from baseline to week 2.

Findings: UP ratings based on the 5D-itch scale decreased for both groups, with a more significant reduction in the mirtazapine group (P = 0.04). The mirtazapine group also showed a significant improvement in the PSQI compared to hydroxyzine (P = 0.01). Dry mouth was the only notable adverse effect, occurring more frequently in the mirtazapine group (P = 0.02).

Conclusion: This study suggests that short-term treatment with mirtazapine is more effective than hydroxyzine in reducing the severity of UP and improving sleep quality for patients undergoing hemodialysis.